here you go

Search Results

You searched for 'SOP'. Your search returned 27 results.

Palliative radiotherapy in addition to self expanding metal stent for improving outcomes of dysphagia and survival in advanced oesophageal cancer (ROCS)

Summary:
The single most distressing symptom for more than 70% of patients with oesophageal cancer is difficulty in swallowing (dysphagia) caused by blockage of the gullet by a tumour. This causes severe restrictions on food intake, physical activity, social functioning and overall quality of life. Amongst the more effective treatments for improving swallowing, is the insertion of a metal stent (Self Expanding Metal Stent or SEMS) across the blocked part, which then self-expands to open up the gullet. The addition of radiotherapy may help to improve the problems caused by dysphagia and provide an additional survival benefit.
The purpose of this study is to test the impact of adding radiotherapy to SEMS on:
i) the length of time swallow remains improved for
ii) quality of life
iii) survival

Patients will be eligible to take part in the trial if they have oesophageal cancer, are in need of SEMS because of dysphagia, are aged 16 years or older, have been clinically assessed to be able to receive radiotherapy, have an expected survival of at least 12 weeks and are able to give written informed consent.
Four hundred and ninety-six patients will be randomised to receive either SEMS alone or SEMS with radiotherapy. The radiotherapy will be given as an outpatient either as five treatments (one per day) over one week, or ten treatments over two weeks. Questionnaires will be completed before treatment, within one week of stent insertion and then four
weeks after stent insertion until death to assess quality of life and cost. Interviews will be held with a sub-set of trial participants at three time points to explore their experiences whilst on the trial. Interviews will also be held with patients who do not consent to take part in the trial to explore their reasons for non-consent.

Inclusion criteria:
1. Histological confirmation of oesophageal carcinoma excluding small cell histology
2. Not suitable for radical treatment (oesophagectomy or radical chemoradiotherapy) either because of patient choice or medical reasons
3. Dysphagia clinically assessed as needing stent as primary treatment of the dysphagia
4. Age 16 or over
5. Discussion and treatment decision for SEMS placement made by an Upper GI multi-disciplinary team
6. Clinician assessment of ability to attend for radiotherapy
7. Expected survival of at least 12 weeks
8. Written informed consent

Exclusion criteria:
1. Histology of small cell carcinoma type
2. Tumour length of greater than 12 cm
3. Tumour growth within 2 cm of the upper oesophageal sphincter
4. Endoscopic treatment of the tumour, other than dilatation, planned in the peri-stent period
5. Presence of a tracheo-oesophageal fistula
6. Presence of a pacemaker
7. Previous radiotherapy to the area of the proposed radiotherapy field
8. Endoscopic treatment of the tumour (e.g. laser) in the immediate peri-stenting period
9. Pregnancy

Principal Investigator for this trial: Mr Ravinder Vohra

Research Ethics Committee Reference: 12/WA/0230

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Randomised Clinical Trial of neoadjuvant and adjuvant chemotherapy (MAGIC regimen) vs. neoadjuvant chemoradiation (CROSS protocol) in adenocarcinoma of the oesophagus and oesophago-gastric junction.

Summary:
Cancer of the oesophagus (gullet/food pipe) and oesophagogastric junction (junction between the oesophagus and stomach) have increased in incidence in the West over the last 25 years. Oesophageal cancer is now the 9th most common cancer in the UK, accounting for 3% of all new cases. The aim of this research study is to compare and evaluate two established treatments for oesophageal cancer in order to establish if one treatment is superior to the other. The research group believe it is not currently clear which regimen is of greatest benefit to patients. These 2
regimens have been tested in previous randomised trials (MAGIC & CROSS). The 2 treatments are either
chemotherapy before and after surgery, or chemotherapy with radiotherapy before surgery. Both treatments are
standard and have been in use as treatments for oesophageal cancer for several years. 594 patients with
oesophageal and oesophagogastric junction cancer will be randomly allocated to these 2 treatments. During the trial patients will have a variety of clinical assessments and will complete health-related questionnaires. Following treatment they will be followed up for 3 years. The main objective of this trial is to look at overall survival. Secondary objectives are patient quality of life, complications and relief of swallowing problems.

Inclusion criteria:
1. Histologically-verified adenocarcinoma of the oesophagus or oesophagogastric junction based on OGD.
2. CT-18FDG-PET in all patients and EUS, if feasible
3. Staging laparoscopy will be performed for tumours of the abdominal oesophagus, junction and proximal stomach i.e. AEG II and AEG III (at the investigator’s discretion)
4. Pre-treatment stage cT23, N03, M0
5. No prior abdominal or thoracic radiotherapy
6. Male/female patients aged >18 years
7. ECOG Performance Status 0, 1 or 2
8. ASA Grading I-II
9. Adequate cardiac function. For all patients an ejection fraction of ≥ 50% is required. If patients have a known
significant cardiac history(e.g. known ischaemic disease, cardiomyopathy) an ejection fraction >50% and cardiac clearance by a consultant cardiologist for major surgery and cancer therapies is required. Where necessary, the Chief Investigator should be consulted to discuss the patient’s eligibility.
10. Adequate respiratory function. Patients should have pulmonary function tests completed with FEV1 >1.5L
11.Adequate bone marrow function: absolute neutrophil count (ANC) >1.5×109/l; white blood cell count >3×109/l;
platelets >100×109/l; haemoglobin (Hb) >9g/dl (can be posttransfusion).
12.Adequate renal function: glomerular filtration rate >60ml/minute calculated using the Cockcroft-Gault
Formula
13.Adequate liver function: serum bilirubin Exclusion criteria:
1. Tumours of squamous histology.
2. Patients with advanced inoperable or metastatic oesophageal, junctional or gastric adenocarcinoma.
3. Any prior chemotherapy for gastrointestinal cancer.
4. Prior abdominal or thoracic radiation.
5. Patients who are unfit for surgery or cancer treatments based on cardiac disease.
6. Patients with acute systemic infections.
7. Patients who are receiving treatment with Sorivudine or it’s chemical related analogues, such as Brivudine, which is contraindicated with capecitabine and 5-Fluorouracil administration.
8. Clinical COPD with significant obstructive airways disease classified by FEV1 Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible).
10. Known positive tests for human immunodeficiency virus (HIV) infection, acute or chronic active hepatitis B infection.
11. Any other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix).
12. Women who are pregnant or who are breastfeeding.

Principal Investigator for this trial: Mr Simon Leslie Parsons

Research Ethics Committee Reference: 14/EM/1284

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett’s Esophagus

Summary:
This study is a post market, multicenter, international, prospective registry to confirm performance of a new, approved device (Captivator™ EMR) for resection of early neoplasia in patients with Barrett’s Esophagus. The Captivator EMR device is indicated for endoscopic mucosal resection (EMR) of the upper gastrointestinal tract. All EMR procedures will be performed per standard of practice at each clinical center.

Inclusion criteria:
1. Age 18-80 years.
2. Barrett’s esophagus with a visible abnormality confirmed upon prior endoscopy. A visible abnormality is described
as meeting one or more of the following definitions:
a. Lesion is detected as visible based on white light imaging with any macroscopic appearance according to the Paris Classification and is also endoscopically resectable.
b. Lesion is detected by narrow band imaging (NBI), but without any other specific characteristics for a visible lesion.
c. Lesion is confirmed to contain high grade dysplasia and/or carcinoma upon prior biopsy.
3. Subject is scheduled for endoscopic resection of present neoplasia
4. Subject is amenable to EMR with no suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography upon earlier endoscopy.
5. Subject is taking PPI BID 40 mg (or equivalent dosage).
6. Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.

Exclusion criteria:
1. Subject has previously undergone endoscopic therapy for esophageal neoplasia, including (but not limited to)
cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation, argon plasma coagulation or radiotherapy.
2. Presence of esophageal stenosis preventing passage of a therapeutic gastroscope.
3. Endoscopically visible scarring by any cause of the intended treatment zone.
4. Esophageal varices.
5. Subject has known or suspected esophageal perforation.
6. Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).
7. Subject refuses or is not able to provide written informed consent.

Principal Investigator for this trial: Dr Krish Ragunath

Research Ethics Committee Reference: 15/EM/0454

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Evaluation of a NonEndoscopic Immunocytological Device (Cytosponge) for Barrett’s Esophagus Screening in a CaseControl Study (BEST 2)

Summary:
Oesophageal cancer is an increasing problem in the western world with a high mortality. Outcomes can be dramatically improved by detecting the precancerous conidtion called Barrett’s oesophagus. We have developed a screening test (Cytosponge coupled with a molecular test) for Barrett’s oesophagus. We now want to use this device to categorise individuals according to their risk for developing cancer. To do this we will use different molecular tests applied to cells collected by the Cytosponge device. The study is a case: control study design in which the cases will be patients with known Barrett’s Oesophagus (BE) and controls individuals with reflux or indigestion (dyspepsia) symptoms referred for endoscopy. Four centres with expertise in Barrett’s oesophagus will recruit patients. All participants will swallow the Cytosponge device prior to having an endoscopy. The Cytosponge will be processed for a number of different biomarkers. The results will be compared with the endoscopy findings.

Inclusion criteria:
Inclusion · Any participant 18 years and above clinically fit for an endoscopy with Barrett’s oesophagus (Cases) with or without upper GI symptoms · Any participant 18 years and above clinically fit for an endoscopy with upper GI symptoms of reflux or dyspepsia as an indication for endoscopy/gastroscopy (Controls) · Ability to provide informed consent

Exclusion criteria:
Exclusion criteria · Individuals with a diagnosis of an oropharynx, oesophageal or gastrooesophageal tumour, or symptoms of dysphagia, · oesophageal varices, stricture or requiring dilatation of the oesophagus · on anticoagulation therapy/medication (warfarin, clopridogrel,heparin or tinzaparin). · Individuals who have had a myocardial infarction or any cardiac event less than six months ago. · Individuals who have had a cerebrovascular event Principal Investigator for this trial: Dr Krish Ragunath

Research Ethics Committee Reference: 10/H0308/71

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Oesophageal Cancer Clinical and Molecular Stratification Study – OCCAMS – A prospective Multicentre Trial of a revised clinical and molecular staging system for Oesophageal and Junctional Adenocarcinoma

Summary:
Cancers that occur at the junction between the oesophagus (gullet) and the stomach are called gastro oesophageal junction (GOJ) adenocarcinomas. They are 6 times more common than they were 30 years ago and have a very poor outcome (only 1 in 5 patients will survive five years). We have previously developed a new way of determining how advanced a patient’s GOJ adenocarcinoma is (what we call staging) using both the physical features determined by the radiology tests and the molecular features of the cancer. This system works significantly better than the existing way we stage these cancers. However this new system was developed using patients who had already had their surgery. We now want to test it on patients at the beginning of their treatment or what we term prospectively. The patients management will not differ from current practice but as well as looking at the features used for staging at the moment we will also record our new system in parallel. We will also test samples of the cancer, which are already routinely taken, for the molecular changes we think will predict survival. After this patients will undergo the standard treatment at each of the centres involved. It will then be possible to determine both how practical our new system is and how good it is at predicting survival. We will be running this prospective trial in multiple hospitals across the country to ensure that our system is broadly applicable. If we can prove that our revised staging system, using both the physical features of the tumour and the molecular changes, can accurately predict outcome this will allow us to give far better information to our patients about their chance of a cure but also it will also allow treatments to be targeted at those who will benefit the most.

Inclusion criteria:
The inclusion criteria is any patient with tissue proven diagnosis of adenocarcinoma (distal oesophageal, and Siewert types I, II and III) being treated with curative intent (oesophagectomy or extended total gastrectomy). The exclusion criteria are patients undergoing palliative treatment and those unable or unwilling to consent.

Principal Investigator for this trial: Mr Simon Leslie Parsons

Research Ethics Committee Reference: 10/H0305/1

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Prospective Study to Evaluate the Safety and Efficacy of Domperidone in 6-month-old to 12-year-old Pediatric Subjects With Nausea and Vomiting Due to Acute Gastroenteritis

Summary:
The main objective of this study is to show that domperidone liquid medicine plus Oral Rehydration Therapy (ORT) is more effective than placebo (a liquid with no active medicine in it) plus ORT at reducing the symptoms of vomiting associated with acute gastroenteritis (AG) within 48 hours of the first successful treatment administration in children, 6 months to 12 years old, with AG and mild-to-moderate dehydration. Domperidone has been approved since 1978 in more than 100 countries for the relief of the symptoms of nausea and vomiting, sense of fullness in upper abdomen, upper-abdominal discomfort, and regurgitation of gastric contents in adults, and for the relief of the symptoms of nausea and vomiting in children.
480 paediatric participants 6 months to 12 years of age will be randomly assigned in this study with 240 participants planned per treatment group (domperidone or placebo).
Participants will receive treatment for 2-7 (maximum) days and will be followed for safety evaluations for about 15 days. The amount of time participants take the study drug may vary depending on how they respond to treatment.
Participants will attend 3 clinic visits, the initial visit, the next day (24 hours later) and then on the last day of the study.
The study is divided into 3 parts:
• Screening: the doctor will check participants are eligible to participate.
• Treatment: Treatment will be between 2 and 7 days.
• Follow-up: The clinic will telephone participants 3 times during the study. These telephone calls will be done on days 3, 4 and 8. They will be asked questions regarding health and vomiting, nausea (in children 4 years of age and older) and diarrhoea episodes. If participants’ symptoms worsen during the study period at any time another clinic visit may be scheduled.

Inclusion criteria:
1. Subject must be a female or male child 6 months to 12 years of age, inclusive.
2. The subject presents with at least 3 episodes of non-bilious, non-bloody vomiting within the 24 hours prior to visiting the physician’s office. The subject has at least 2 signs and symptoms other than vomiting consistent with AG (i.e. fever [see note below], nausea, diarrhoea, abdominal pain, bloating, or discomfort) within 3 hours prior to visiting the clinic;
3. The subject has mild-to-moderate dehydration as per the Dehydration Score Assessment;
4. The subject had at least 1 episode of non-bloody diarrhoea within the 24 hours prior to the visiting the clinic.

Note: In children 6 months to 12 years of age a fever will be defined as:
1) >38.0o C or 100.4o F if temperature taken via rectal or ear thermometer
2) >37.6o C or 99.6o F if temperature taken via oral or axillary thermometer

Exclusion criteria:
Any potential subject who meets any of the following criteria will be excluded from participating in the study.
1. The subject has severe dehydration or severe malnutrition;
2. The subject who has vomiting and clinical symptoms for longer than 72 hours prior to the baseline visit;
3.The subject needs IV fluid replacement;
4.The subject has chronic severe diarrhoea, a previous history of Helicobacter pylori infection or received treatment for H. pylori-induced gastritis, active peptic ulcer, celiac disease, Crohn’s disease, ulcerative colitis, eosinophilic esophagitis, malabsorption, short bowel syndrome, post-viral gastroparesis, cyclic vomiting syndrome, or previous gastrointestinal surgery;
5. The subject has upper respiratory symptoms such as cough, congestion, otitis media or pharyngitis;
6. The subject has received any anti-emetic medication within the 24 hours prior to the signing of the informed consent form or requires it during the course of the study.;
7. The subject has a known allergy to domperidone or to any components of the domperidone formulation;
8. The subject has a significant cardiac history including congenital heart disease, bradycardia, hypotension, Torsades de Pointes, heart failure, chronic hypokalaemia, a personal diagnosis or family history of Long-QT Syndrome; or a patient history of congenital neural deafness or syndactyly.
9. Subjects with clinical symptoms typically associated with the arrhythmias that could be the result of QT-prolongation: Heart palpitations, irregular heartbeat, lightheadedness, fainting, seizures, weakness, and blurred vision;
10. Subjects with extrapyramidal symptoms such as involuntary movements of the face or arms (boxing arm movements) and legs (cycling leg movements), excessive trembling, excessive muscle stiffness, muscle spasm or back and neck arching in infants and younger children or increased frequency of blinking of both eyelids, finger movement (finger movements often resemble playing ‘Air Guitar’), pulling the head to the side (torticollis) or forward and down (antecollis), and abnormal chewing motions (biting with nose wrinkling) in older children;
11. The subject has hepatic insufficiency or renal insufficiency;
12. The subject has a history of serious illnesses, including obstructive uropathy, pancreatitis, carcinoma, pulmonary, endocrine, neurological, psychiatric, or metabolic disturbances and diabetes mellitus or diabetes insipidus;
13. The subject has participated in an investigational study within 30 days prior to the screening visit;
14. The subject has received any prokinetic, anti-emetic, potent CYP3A4 inhibitor or QT-prolonging medication within the 24 hours prior to the signing of the informed consent/assent form or requires it during the treatment phase of the study;
15. The subject, if female, has reached menarche.

Principal Investigator for this trial: Dr David Devadason

Research Ethics Committee Reference: 16/YH/0154

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Albumin To prevenT Infection in chronic liveR failurE (ATTIRE)

Summary:
Liver disease is the fifth most common cause of death in the UK and is caused largely by alcohol, viruses and fatty liver disease resulting in liver damage and loss of function. People can survive with large amounts of liver damage but often have severe health complications leading to frequent hospital admissions. In particular, patents have weak immune systems and are highly prone to bacterial infection with over a third developing an infection in hospital. Infection is the major cause of death in these patients and therefore represents a huge challenge to the NHS.

Currently infection in liver patients is treated with antibiotics, however the rates of death in these patients have shown little improvement over 20 years. Antibiotics may also cause harmful side-effects (e.g. diarrhoea) and overuse has led to antibiotic resistant bacteria which makes these drugs useless and will be one of medicines’ greatest challenges over the next decade.

Our study aims to see if giving liver patients Human Albumin Solution restores their immune response and helps both prevent and improve treatment of infections. Albumin is a protein found naturally in blood and is made in the liver. As liver function reduces so does albumin production and blood levels fall. Albumin is safe and currently used in patients with liver failure; however, prescription is varied and although considered beneficial the effects haven’t been tested in clinical trials.

This study includes a feasibility study, to verify whether it is possible to restore albumin levels to near normal. This will be followed by a randomised control trial to confirm whether restoring albumin levels improves survival from infection compared to standard treatment.

The study will take place at up to 40 NHS sites in England, Wales and Scotland involving 946 patients and is supported by the Department of Health and the Wellcome Trust.

Inclusion criteria:
• All patients admitted to hospital with acute onset or worsening of complications of cirrhosis e.g. alcoholic hepatitis, hepatic encephalopathy, ascites, hepatic hydrothorax, hyperbilirubinaemia, oesophageal variceal bleed, any infection precipitating acute decompensation or any other presentation of acute decompensation / acute onset chronic liver failure
• Over 18 years of age
• Predicted hospital admission > 5 days at trial enrolment, which must be within 72 hours of admission
• Serum albumin Exclusion criteria:
• Advanced hepatocellular carcinoma with life expectancy of less than 8 weeks
• Patients who will receive palliative treatment only during their hospital admission
• Patients who are pregnant
• Severe cardiac dysfunction
• Any clinical condition which the investigator considers would make the patient unsuitable for the trial
• The patient has been involved in a clinical trial of Investigational Medicinal Products (IMPs) within the previous 30 days (including re-randomisation into the RCT)
• Trial investigators unable to identify the patient (by NHS number)

Principal Investigator for this trial: Dr Stephen D Ryder

Research Ethics Committee Reference: 15/LO/0104

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Digital Health Records

The Digital Health Records (Unity) system is designed, built and tested to meet information governance and data protection requirements.
All NUH staff accessing DHR Unity must adhere to NUH Trust policies in relation to patient confidentiality and data protection.
The DHR … Continue reading

A prospective, multicenter, randomised, open-label, active controlled, two-parallel groups, phase 3 study to compare the efficacy and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imatinib at 400mg as first line treatment.

Summary:
Gastrointestinal stromal tumors (GIST) are uncommon visceral sarcomas that arise in the stomach (60-70%), small intestine (20-30%), colon and rectum (5%) and oesophagus (Inclusion criteria:
1. Patient with histological proven non-operable locally advanced or metastatic Gastro Intestinal Stromal Tumour (GIST)
2. Patient with measurable tumor lesions with longest diameter ≥(greater than or equal to) 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
3. Patient with Ckit (CD117) positive tumour detected immuno-histochemically
4. Patients after progression with imatinib at the dose of 400 mg/day as first line of treatment. Progression is defined as a RECIST 1.1 disease progression under imatinib treatment
5. Patient with ECOG ≤(less than or equal to) 2
6. Patient with adequate organ functions:
• Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
• Haemoglobin ≥ 10 g/dL
• Platelets (PTL) ≥ 75 x 109/L
• AST/ALT ≤ 2.5x ULN (≤ 5 x ULN in case of liver metastases)
• Gamma GT 1 x LLN
• Urea ≤ 2 x ULN
• Proteinuria 6 months
8. Male or female patient, age >18 years
9. Patient with a BMI > 18 kg/m² and weighing at least 40kg
10. Male and female patient of child bearing potential, (for female entering the study after a menstrual period and who have a negative pregnancy test at baseline) must agree to use two effective methods of contraception, one highly effective and one additionally effective or to practice abstinence from heterosexual contact during the study and for 3 months after the last treatment intake.
The following are examples of highly effective and additional effective methods of contraception:
Highly effective methods:
– Intrauterine device (IUD)
– Hormonal (birth control pills, injections, implants)
– Tubal ligation
– Partner’s vasectomy
Additional effective methods:
– Male condom
– Diaphragm
– Cervical Cap
This protocol defines a female of childbearing potential as a sexually mature woman who has not undergone a
hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal (amenorrhea following cancer
therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
11. Patient able and willing to comply with study procedures as per protocol
12. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
13. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment
14. Patient affiliated to a social security regimen (for France only) and/or covered by insurance reimbursing sunitinib

Exclusion criteria:
1. Patient treated for a cancer other than GIST within 5 years before enrolment, with the exception of basal cell
carcinoma or cervical cancer in situ.
2. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
3. Patient presenting with cardiac disorders defined by at least one of the following conditions:
• Patient with recent cardiac history (within 6 months) of:
– Acute coronary syndrome
– Acute heart failure (class III or IV of the NYHA classification)
– Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
• Patient with cardiac failure class III or IV of the NYHA classification
• Patient with severe conduction disorders which are not prevented by permanent pacing (atrioventricular
block 2 and 3, sinoatrial block)
• Syncope without known aetiology within 3 months
• Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
4. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
5. Pregnant, or nursing female patient
• Previous treatment
6. Known hypersensitivity to sunitinib or masitinib or to any of the exicipients
7. Patient previously treated with a dose of imatinib > 400mg
8. Patient intolerant to imatinib
9. Previous treatment with sunitinib or kinase inhibitor other than imatinib
• Washout
10. Treatment with any investigational agent within 4 weeks prior to baseline
11. Previous imatinib treatment should be permanently discontinued within 4 days prior randomisation and patient should have recovered from potential toxicity related to imatinib

Principal Investigator for this trial: Dr Ivo Hennig

Research Ethics Committee Reference: 13/WS/0228

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

SKELETAL MUSCLE METABOLISM AND FUNCTION IN INFLAMMATORY DISEASE: A PILOT STUDY IN CROHN’S DISEASE AND NON-ALCOHOLIC FATTY-LIVER DISEASE WITH COMPENSATED CIRRHOSIS

Summary:
Crohn’s Disease (CD) and non-alcoholic fatty liver disease (NAFLD) are both inflammatory diseases where commonly, sufferers are unable to get enough nutrition from the food they eat. In CD, up to 75% of hospitalized patients are malnourished, when it comes to paediatric CD, 60% of newly-diagnosed children have weight loss,with decreased
growth and malnutrition showing several years after diagnosis in 15% of children.This is seen as loss of muscle, causing a constant feeling of tiredness and fatigue.

NAFLD affects children, adolescents and adults alike. Sufferers also have problems in being able to get the right
amount of nutrients from the food they eat which can lead to muscle loss.

Both Patients with CD and NAFLD experience loss of muscle mass which has a negative effect on physical activity and patient well-being. It is not yet clear how much of an affect CD and NAFLD disease, diet and physical activity have on muscle function. In this study we plan to measure the effects of food intake and a programme of exercise on muscle and its function in CD and NAFLD and compare this with Healthy Volunteer Controls.We will recruit participants to each of the following groups:

• Patients with active Crohn’s disease
• Patients with Crohn’s disease in remission
• Patients with NAFLD
• Patients with NAFLD compensated cirrhosis
• Age, BMI and gender matched healthy volunteers

Inclusion criteria:
Healthy Volunteers:Age/Sex BMI-matched.

-Age: 11-75 years

Crohns Patients:
-Age 18-75 years
-BMI of 250μg/g or
•CReactive protein >5mg/dl or,
•Harvey-Bradshaw index score of 516.

NAFLD Patients: Age 11-75 years:
-Non-Cirrhotic as define by recent ultrasonography evidence of a hyperechoic liver due to NAFLD with no alternative cause identified in the absence of cirrhosis.

NAFLD patients with Cirrhosis (Aged 18-75yrs)
who have at least ONE of the following:
•Histological analysis
•Validated non-invasive fibrosis test
•Presence of oesophageal varices, radiological features and/or clinical findings (2 out of 3 required). Alcohol consumption will be less than 21 units per week for men and 14 units for women.

Exclusion criteria:
Any Potential participants(CD, NAFLD and HVs) with any of the following criteria will be excluded:
•Stricturing or penetrating CD
•History of major abdominal resections in the last 12 months
•Corticosteroid use in the last 3 months prior to inclusion
•Corticosteroid-dependent CD disease (defined as a patient who is unable to reduce steroids below the equivalent of
prednisolone 10mg/day or budesonide 3mg/day within 3 months of recruitment).
•CD patients treated with elemental diet
•Other aetiologies of chronic liver disease, specifically alcohol or drug induced liver disease, autoimmune or viral
hepatitis, cholestatic or metabolic/genetic liver disease by specific clinical, biochemical, radiographic and /or histological criteria.
•Severe CD or cirrhosis where a delay in a change in medical treatment for 1 week would not be clinically advisable.
•Significant cardiovascular or respiratory disease
•Thyroid disease
•Neurological or cognitive impairment
•Significant renal failure
Pregnancy or breastfeeding. Participants will be informed before the DEXA scan that pregnancy is an exclusion and
standard NHS procedures will be followed – pregnancy
tests will be available in the female toilets of the Physiology Unit for self-testing.

•Abnormalities on screening blood tests (that CI deems as clinically significant)
•>5mSv ionizing radiation exposure in the past 12 months

Principal Investigator for this trial: Dr Gordon Moran

Research Ethics Committee Reference: 15/WM/0285

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

A phase III doubleblind placebocontrolled randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common nonmetastatic solid tumours.

Summary:
Add-Aspirin is a large clinical trial for people who have had treatment for breast, colorectal, gastro-oesophageal
or prostate cancer. The aim of the trial is to find out whether taking aspirin regularly after treatment for early stage cancer stops or delays the cancer coming back.
Participants will self-administer 100mg aspirin once daily for 8 weeks. After 8 weeks, if taking regular aspirin does not cause any serious problems, participants will be randomly allocated to self-administer either a 300mg aspirin tablet, a 100mg aspirin tablet or a placebo tablet once daily for at least five years. Participants who are 75 years old or over, will only be allocated to 100mg aspirin tablets daily or placebo tablets. To ensure the results of the trial are as reliable as possible, neither the participants, nor the clinicians will know which tablets participants are allocated to.
In total, 9,920 participants will be randomised into the trial over 3 – 6 years (depending on tumour site). All participants will be followed-up within the trial for at least 5 years. In the UK, long-term follow-up data will also be obtained from routinely-collected healthcare databases.
A programme of associated correlative science is planned incorporating both short and long-term projects which will
investigate key questions including: determining the mechanism of action for an anti-cancer effect of aspirin;
determining biomarkers that identify participants most likely to experience serious aspirin-related toxicity; determining the roles of genotypic and phenotypic differences in aspirin’s actions; identifying individuals who will benefit most or least from aspirin and determining the mechanisms underlying potential non-cancer benefits of aspirin.

Inclusion criteria:
COMMON INCLUSION CRITERIA
1. Written informed consent
2. WHO performance status 0, 1 or 2
3. Previous or current participants of other primary treatment trials if agreed in advance between trials
4. No clinical or radiological evidence of residual or distant disease
BREAST COHORT INCLUSION CRITERIA
1. Men or women with histologically confirmed invasive breast cancer
2. Undergone complete primary invasive tumour excision with clear margins
3. Surgical staging of the axilla must have been undertaken by sentinel node biopsy, axillary sampling or dissection
4. In those patients with a positive sentinel node biopsy:
a. If 1, 2 or 3 nodes are positive, subsequent management of the axilla (with surgery, radiotherapy or no further
intervention) should be completed prior to registration
b. If 4 or more nodes are involved, patients must have undergone completion axillary node dissection
5. Radiotherapy (RT)
a. Patients who have undergone breastconserving
surgery should receive adjuvant RT
b. Patients who have undergone mastectomy should receive RT if they have more than 3 axillary lymph nodes involved
c. Patients who have undergone mastectomy and have T3 tumours and/or 1, 2 or 3 involved lymph nodes may (or not)
receive radiation per institutional practice
6. Final histology must fall within at least one of these 3 groups:
a. Node positive
b. Node negative with high-risk features -2 or more of:
i. ER negative
ii. HER2 positive
iii. Grade 3
iv. Lymphovascular invasion present
v. Age 25
c. In patients who have received neo-adjuvant
chemotherapy, patients are eligible if they have both a hormone receptor negative/HER2 negative tumour, a HER2 positive tumour or a hormone receptor positive grade 3 tumour and did not achieve a pathological complete response with neoadjuvant systemic therapy
7. Patients who received standard neoadjuvant
and/or adjuvant chemotherapy or RT are eligible.
8. Known HER2 and ER status
9. Participants may receive endocrine therapy and trastuzumab. All ER positive patients should be planned to undergo at least 5 yrs of adjuvant endocrine therapy
COLORECTAL COHORT INCLUSION CRITERIA
1. Histologically confirmed stage II or III adenocarcinoma of the colon or rectum and patients who have undergone
resection of liver metastases with clear margins and no residual metastatic disease
2. Patients with synchronous tumours if one of the tumours is at least stage II or III
3. Serum CEA ideally ≤1.5 x upper limit of normal
4. Have undergone curative (R0) resection with clear margins
GASTRO-OESOPHAGEAL
COHORT INCLUSION CRITERIA
1. Patients with histologically confirmed adenocarcinoma, adenosquamous carcinoma or squamous cell cancer of the
oesophagus, gastro-oesophageal
junction or stomach
2. Have undergone curative (R0) resection with clear margins or primary chemoRT given with curative intent
PROSTATE COHORT INCLUSION CRITERIA
1. Men with histologically confirmed node negative non-metastatic adenocarcinoma of the prostate
2. Have undergone curative treatment, either:
a. Radical prostatectomy
b. Radical RT
c. Salvage RT (following rise in PSA after prostatectomy)
3. Intermediate or high risk according to D’Amico classification

Treatment pathway specific inclusion criteria:
(a) Prostatectomy patients
4. Open, laparoscopic or robotic radical prostatectomy
5. Men treated with immediate adjuvant RT
6. Men receiving adjuvant hormone therapy planned for a maximum duration of 3 yrs
7. Men randomised to any of the 3 arms of RADICALS HD are eligible
(b) Radical RT patients
9. Men receiving neo-adjuvant and/or adjuvant hormone therapy planned for a maximum duration of 3yrs
(c) Salvage RT patients following PSA rise after previous radical prostatectomy
13. Men treated with salvage RT following a rise in PSA are eligible
14. Men receiving neo-and/ or adjuvant hormone therapy planned for a maximum of 3yrs
15. Men randomised to any of the 3 arms of RADICALS HD are eligible

Exclusion criteria:
COMMON EXCLUSION CRITERIA
1. Current or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication.
2. A past history of adverse reaction or hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or
sulphonamides, including asthma, that is exacerbated by use of NSAIDs.
3. Current use of anti-coagulants.
4. Current or long-term use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to long-term
therapy.
5. Active or previous peptic ulceration or gastrointestinal bleeding within the last year, except where the cause of
bleeding has been surgically removed.
7. Active or previous history of inflammatory bowel disease.
8. History of moderate or severe renal impairment, with eGFR3 years.
3. Bilateral orchidectomy.

Principal Investigator for this trial: Dr Vanessa Potter

Research Ethics Committee Reference:

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

International randomised controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma

Summary:
rEECur is a randomised study to compare four chemotherapy regimens to see which is the best at treating recurrent or refractory Ewing sarcoma. Ewing sarcoma is a type of bone cancer. Recurrent Ewing sarcoma means Ewing sarcoma that has come back after being treated. Refractory Ewing sarcoma means Ewing sarcoma that has grown or progressed while being treated. Ewing sarcoma is rare and running a study such as this requires funding and
collaboration across many different treatment centres and countries. The logistics behind running such a study are
not trivial and as a result rEECur is the first study to directly compare different chemotherapy regimens in this disease setting.
Most doctors treat recurrent and refractory Ewing sarcoma with chemotherapy. However, although several
chemotherapy regimens are available to treat this disease, we do not know which is the best regimen to use. We are
primarily interested in finding out which regimen is most effective at making tumour deposits shrink and, in the longer term, at curing the disease or providing prolonged disease control. We will also determine which regimen has the most side effects, which is associated with the most time spent in hospital and which has the greatest effect on quality of life.
The results will help us to know which chemotherapy regimen is the best to use for patients with this disease. It will also allow us to inform patients about the relative burden of side effects associated with each regimen, allowing individual patients and/or parents to make an informed choice about how to be treated.

Inclusion criteria:
1. Histologically confirmed Ewing sarcoma.
2. Disease recurrence or progression after completion of first line treatment OR Refractory disease, defined by progression during first line treatment or within 12 weeks of its completion. Disease progression will be based on Response Evaluation Criteria In Solid Tumors (RECIST). The appearance of new bone lesions on bone scan will require confirmation with cross-sectional imaging.
3. Soft tissue disease component evaluable by cross-sectional imaging. Patients with bone disease without a
measurable soft tissue component or bone marrow disease only will be eligible for the study but will not contribute to
the phase II primary outcome measure.
4. Age ≥4 years and Exclusion criteria:
1.Bone marrow infiltration resulting in absolute neutrophil count (ANC) Principal Investigator for this trial: Dr Sophie Wilne

Research Ethics Committee Reference: 14/NW/1110

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Research contracts frequently asked questions

Below is a list of frequently asked questions relating to research contracts. If you need further assistance then please contact either Amy Grattan, Hannah Driver or Ed Stimpson in the Research Awards team; contact information for all teams can … Continue reading

Pre Award Support Service – compilation of research grant funding applications

What we do
It takes time to develop a good application and so you must ensure you have the correct support from your peers and directorate. Help and support is available from R&I who will enable you to consider all … Continue reading

Efficacy and safety of MRI based thrombolysis in wakeup stroke: a randomised, doubleblind, placebocontrolled trial

Summary:
About 20% of strokes occur during sleep, and in many other cases the time of onset cannot be determined because of
communication difficulties resulting from the stroke and lack of a witness. For patients waking up with stroke
symptoms, or those with unknown time of onset, the only approved treatment — the delivery of the thrombolytic (“clot
busting”) drug rtPA — is unavailable to them. Currently, rtPA has only been proven effective when given to patients
within 4.5 hours after the onset of stroke symptoms, and because there is concern about the risk of bleeding
associated with treatment if given later, patients are not eligible for rtPA treatment if the onset time is unknown.
The WAKE-UP trial will test the safety and effectiveness of rtPA treatment in patients who wake with stroke symptoms
or have unknown onset time by using brain scanning with Magnetic Resonance Imaging (MRI) to identify whether the
stroke was likely to have happened within the 4.5 hour time window. This can be done with a combination of two types
of MRI scan, one that shows changes very quickly (diffusion-weighted imaging, DWI), and one where the changes take
several hours to become obvious (FLAIR). Previous studies have shown that scans where the DWI is abnormal but the
FLAIR normal identify patients with symptoms that started within 4.5 hours accurately. Patients with this appearance
will be randomly allocated to receive intravenous rtPA or placebo, and followed up for 90 days to assess outcome.

Inclusion criteria:
Clinical Inclusion Criteria
Clinical diagnosis of acute ischemic stroke with unknown symptom onset (e.g., stroke symptoms recognized on
awakening)
Last known well (without neurological symptoms) >4.5 hours of treatment initiation
Measurable disabling neurological deficit (defined as an impairment of one or more of the following: language, motor
function, cognition, gaze, vision, neglect)
Age 18-80 years
Treatment can be started within 4.5 hours of symptom recognition (e.g., awakening)
Written informed consent by patient or proxy
Imaging Inclusion Criteria:
Acute stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR)
completed and showing a pattern of “DWI-FLAIR-mismatch”, i.e. acute ischemic lesion visibly on DWI (“positive DWI”) but no marked parenchymal hyperintensity visible on FLAIR (“negative FLAIR”) indicative of an acute ischemic lesion ≤4.5 hours of age

Exclusion criteria:
Clinical Exclusion Criteria
Planned or anticipated treatment with endovascular reperfusion strategies (e.g. intra-arterial thrombolysis,
mechanical recanalization techniques)
Pre-stroke disability (inability to carry out all daily activities, requiring some help or supervision, i.e. slight disability
corresponding to an MRS score >1)
Participation in any investigational study in the previous 30 days
Severe stroke by clinical assessment (e.g. NIHSS >25)
Hypersensitivity to Alteplase or any of the excipients
Pregnancy or lactating (formal testing needed in woman of childbearing potential childbearing potential is assumed
in women up to 55 years of age)
Significant bleeding disorder at present or within past 6 months
Known haemorrhagic diathesis
Manifest or recent severe or dangerous bleeding
Known history of or suspected intracranial haemorrhage
Suspected subarachnoid haemorrhage (even if CT is negative) or condition after subarachnoid haemorrhage from
aneurysm
History of CNS damage (e.g. neoplasm, aneurysm, intracranial or spinal surgery)
Recent (within 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible
blood-vessel
Current use of anticoagulants (e.g. Phenprocoumon, Warfarin, new anticoagulants such as Dabigatran) or current
use of heparin and elevated thromboplastin time (lowdose subcutaneous heparin is allowed)
Platelet count 400 mg/dl (185 mmHg or diastolic blood pressure >110 mmHg
or requiring aggressive medication to maintain blood pressure within these limits (routine medical treatment is
allowed to lower the blood pressure below these limits)
Manifest or recent bacterial endocarditis, pericarditis
Manifest or recent acute pancreatitis
Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial aneurysm,
arterial/venous malformations
Neoplasm with increased bleeding risk
Manifest severe liver disease including hepatic failure, cirrhosis, portal hypertension and active hepatitis
Major surgery or significant trauma in past 3 months
Stroke within 30 days
Life expectancy 6 months or less by judgement of the investigator
Any condition associated with a significantly increased risk of severe bleeding not mentioned above
Any contraindication to MRI (e.g. cardiac pacemaker)
Imaging Exclusion Criteria:
Poor MRI quality precluding interpretation according to the study protocol
Any sign of intracranial haemorrhage on baseline MRI
FLAIR showing a marked parenchymal hyperintensity in a region corresponding to the acute DWI lesion inidicative of
an acute ischemic lesion with a high likelihood of being > 4.5 hours old
Large DWI lesion volume > 1/3 of the MCA or >50% of the anterior cerebral artery (ACA) or posterior cerebral artery
(PCA) territory (visual inspection) or >100 ml
Any MRI findings indicative of a high risk of symptomatic intracranial haemorrhage related to potential IVt-PA treatment
in the judgement of the investigator

Principal Investigator for this trial: Dr Ashit Shetty

Research Ethics Committee Reference: 12/SS/0211

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Pilot study to investigate the early prediction of toxicity following induction chemotherapy in Ewing’s sarcoma by bloodborne biomarkers and correlation with agedependent pharmacokinetic variation

Summary:
Ewing’s sarcoma is a bone cancer most commonly diagnosed in teenagers. Current treatment strategies result in approximately 60% of patients being cured but with serious sideeffects often associated with treatment. Routine tests do not accurately predict who will be cured or will experience increased side effects. By learning about what happens to the key drugs administered to Ewing’s sarcoma patients following administration, how they are broken down and what factors are important in determining response and toxicity, we will look to improve treatment strategies. This may be particularly important for teenagers and young adults, who may handle drugs differently than younger children. Modifying drug doses for different patient groups will allow the achievement of drug exposures which are most likely to be beneficial, whilst minimising commonly observed and often severe sideeffects. As part of the same clinical trial we shall also perform a series of blood tests that predict sideeffects of chemotherapy in some adult patients, to see if they are helpful in children to allow us to target those children for extra support and treatment. Improved management of cancer patients is anticipated by adjusting treatment of future patients based on differences in drug exposure and expression of biomarkers predictive of response to treatment and toxicity. Although the study focuses on children with Ewing’s sarcoma, the drugs involved in the treatment of this disease and the findings of the study will be applicable across many different types of sarcoma.

Inclusion criteria:
a) Diagnosis of histologically confirmed Ewing sarcoma. b) Receiving VIDE or VDC/IE as part of standard clinical treatment. c) Single or double lumen central venous catheter in place. d) Written informed consent. e) Protocol approval by national and local ethics committee, regulatory authority and Trust R&D Departments.

Exclusion criteria:
a) Receiving nonstandard dose chemotherapy. b) Glomerular filtration rate Principal Investigator for this trial: Dr Sophie Wilne

Research Ethics Committee Reference: 13/NE/0225

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Templates and Forms

Please refer to this page frequently to ensure the correct template or form is used.
All templates and forms are linked to a Standard Operating Procedure (SOP)
TAFQ00701 Standard Operating Procedure Signature Log
Please note some of the forms listed below are also … Continue reading

Hemostasis of Active GI Luminal Tract Bleeding (HALT)(study # 10017)

Summary:
Duodenal and gastric ulcers (termed peptic ulcers) are common occurences. Bleeding from these ulcers is one of the
commonest reasons for admission to hospital causing significant clinical and economic burden and resulting in
17,000-20,000
hospital admissions per year in the UK. In the last two decades there have been major advances in the clinical and
endoscopic management of peptic ulcer bleeding. However, mortality remains high at around 10%,particularly in the
elderly and in those with significant other diseases. The National Institute for Clinical Excellence
(NICE) has issued guidance on the management of peptic ulcer bleeds and recommend the early use of endoscopy
(an instrument used to visualize the gastrointestinal tract) to diagnose the source of bleeding and to provide
treatment.Currently we use three different modalities to treat peptic ulcer bleeding: a) injection of adrenaline, b)the use
of electrocautery and c)the use of mechanical devices such as clips. Most of these techniques require direct tissue
contact to stop the bleeding and this can be technically challenging. Therefore, in a number of cases either the
bleeding cannot be controlled at the time of the index endoscopy or there is recurrent bleeding within 72 hours of the
first bleed. Recently a new technique called Hemospray (Cook Medical) has been shown to be effective in controlling
bleeding from peptic ulcers. This technique utilises application of non toxic proprietary powder that is applied onto the
bleeding site via endoscope using a catheter in short spray bursts. The powder adheres to the bleeding source and
rapidly achieve control of bleeding. This study will evaluate the effectiveness of Hemospray to control the more serious
(NICE) has issued guidance on the management of peptic ulcer bleeds and recommend the early use of endoscopy
(an instrument used to visualize the gastrointestinal tract) to diagnose the source of bleeding and to provide
treatment.Currently we use three different modalities to treat peptic ulcer bleeding: a) injection of adrenaline, b)the use
of electrocautery and c)the use of mechanical devices such as clips. Most of these techniques require direct tissue
contact to stop the bleeding and this can be technically challenging. Therefore, in a number of cases either the
bleeding cannot be controlled at the time of the index endoscopy or there is recurrent bleeding within 72 hours of the
first bleed. Recently a new technique called Hemospray (Cook Medical) has been shown to be effective in controlling
bleeding from peptic ulcers. This technique utilises application of non toxic proprietary powder that is applied onto the
bleeding site via endoscope using a catheter in short spray bursts. The powder adheres to the bleeding source and
rapidly achieve control of bleeding. This study will evaluate the effectiveness of Hemospray to control the more serious
bleeds from peptic ulcers (termed Forrest Ia and Ib)

Inclusion criteria:
Patient requires hemostasis for nonvariceal GI bleeding. Specifically, the patient must have an actively bleeding peptic
ulcer with a Forrest score of 1a or 1b (spurting or oozing)

Exclusion criteria:
 Patient is 1.5

Principal Investigator for this trial: Dr Krish Ragunath

Research Ethics Committee Reference: 13/YH/0334

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multicentre randomised controlled trial

Summary:
Standard treatment for hydrocephalus is the insertion of a ventriculoperitoneal shunt (VPS). These types of shunt drain
excess fluid from the ventricles in the brain into the peritoneal cavity in the abdomen.
There are currently three main types of VPS on the market in the UK Bactiseal (antibiotic impregnated), Silverline
(Silver impregnated) and standard (silicone, non-impregnated). Currently there are no NICE guidelines or standard
practice advice as to which of these is most effective at reducing infection.
Through this trial we intend to find out which of the three types of VPS listed above is the most effective in reducing
infection. The long term goal thereafter is to inform NHS policy and to ensure standardisation of care and infection
rates across the country. The study aims to recruit 1200 participants (adults and children) who have been newly
diagnosed with hydrocephalus and who require their first VPS. The participants will be recruited from 15 hospitals in
the UK and Ireland. Each patient who enters the trial will be given either a Bactiseal VPS, a Silverline VPS or a standard
silicone VPS. Only the surgical team inserting the VPS will know which VPS the participant has been given.
Information about the study participants will be collected at their routine hospital visits following surgery. In addition,
they will be sent a questionnaire and contacted by phone every three months to collect information about their quality of
life.
For each study participant we will record details of any further surgery related to their shunt, and details of any
infections present.

Inclusion criteria:
1. Newly diagnosed hydrocephalus of any aetiology (including idiopathic intracranial hypertension)
2. VPS is the primary treatment option
3. Clear CSF sample at the time of shunt insertion
Please note the following:
a. Failed primary endosopic third ventriculostomy allowed
b. Previous indwelling ventricular access device (e.g. Ommaya or Rickham reservoir or similar) allowed
c. Previous indwelling EVD allowed

Exclusion criteria:
1. Previous indwelling VPS
2. Active and on-going CSF or peritoneal infection
3. Multi-loculated hydrocephalus requiring multiple VPS or neuro-endoscopy
4. Ventriculo-atrial or ventriculo-pleural shunt planned

Principal Investigator for this trial: Mr Donald C MacArthur

Research Ethics Committee Reference: 13/SS/0084

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing’s Sarcoma Family of Tumours

Summary:
The treatment for Ewing’s sarcoma consists of three phases: induction chemotherapy, local control (surgery and/or radiotherapy) and consolidation chemotherapy. The Euro Ewing 2012 trial is an international, phase III, openlabel, randomised controlled trial which asks several research questions simultaneously. All patients are randomised at trial entry to receive either the current European treatment strategy or the American equivalent. The European strategy consists of VIDE induction chemotherapy and VAI/VAC (riskadapted) consolidation chemotherapy, whilst the American strategy consists of compressed VDC/IE induction chemotherapy and IE/VC consolidation chemotherapy. The objective is to compare these two strategies with respect to clinical outcome and toxicity. There are three options for randomisation at R2 depending on the patient’s disease status at diagnosis and response following induction chemotherapy. Patients fall into one of the following groups: 1) localised disease and good histological response/small tumour volume these patients are eligible for R2zol 2) localised disease and poor histological response/large tumour volume these patients are eligible for R2loc 3) pulmonary/pleural metastases at diagnosis these patients are eligible for R2pulm The objectives of the R2zol randomisation is to determine whether the addition of zoledronic acid to consolidation chemotherapy is associated with improved clinical outcome. The objective of the R2loc and R2pulm randomisations is to compare highdose chemotherapy (busulfan and melphalan) and stem cell transplantation support with the assigned consolidation chemotherapy from the R1 randomisation.

Inclusion criteria:
· Histologically confirmed ESFT of bone or soft tissue · Localised or pulmonary and/or pleural metastatic disease · Age >2 years and Exclusion criteria:
· Extrapulmonary metastatic disease · Contraindication to the treatment in either of the R1 treatment arms · Second malignancy · Pregnant or breastfeeding women · Followup not possible due to social, geographic or psychological reasons

Principal Investigator for this trial: Dr Sophie Wilne

Research Ethics Committee Reference: 12/NW/0827

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

A pilot study to assess the efficacy of intravenous iron isomaltoside 1000 (Monofer) in the management of anaemia associated with the palliative management of upper gastrointestinal adenocarcinoma.

Summary:
There are approximately 16,000 people diagnosed with cancer of the stomach or gullet each year. Unfortunately, these cancers are often inoperable at the time of diagnosis, leaving palliative chemotherapy as the only treatment option available. This chemotherapy regimen is potentially a lengthy course of treatment lasting up to 6 months. As the primary tumour is not removed, it may continue to bleed over this period causing the patient to chronically lose blood, and anaemia to develop. This can be worsened by the side effects of chemotherapy and compounded by reduced oral intake due to swallowing problems from the tumours themselves. Anaemia is associated with symptoms such as breathlessness, chest pain, lethargy and dizziness. If untreated, these symptoms can seriously impact on patients’ quality of life and the ability to complete chemotherapy. Oral iron supplementation has been the mainstay of outpatient treatment for such anaemia. However, some patients do not tolerate it due to gastrointestinal sideeffects and difficulty swallowing the tablets due to the tumour. If such measures fail, then blood transfusions may be required. These are associated with the risk of transmission of infection and allergic reactions, hence clinicians often have a higher threshold for administrating them to treat patients’ symptoms. Intravenous iron has been used effectively to treat anaemia in other conditions but there is a lack of evidence to prove it’s use in this context. This study thus aims to investigate the efficacy and safety of intravenous iron in the palliative management of upper gastrointestinal cancers.

Inclusion criteria:
1.Anaemic as defined by local laboratory normal range(MalesExclusion criteria:
1. Patients who following investigation do not have a histological diagnosis of upper GI adenocarcinoma. 2. Female participants who are pregnant, lactating or planning a pregnancy during the course of the study. 3. Patients with evidence of iron overload or disturbances in utilisation of iron as stated in the product SPC. 4. Known haematological disease that, in the investigators opinion would confound any changes in blood results. 5. Features necessitating urgent surgery at inclusion 6. Previous allergy to intravenous iron or related iron products. 7. Patients who are unable to consent. 8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. 9. Donation of blood during the study. 10.Prisoners and minors (Principal Investigator for this trial: Mr Austin Acheson

Research Ethics Committee Reference: 13/EM/0069

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

SIOP CNS GCT II. Prospective Trial for the diagnosis and treatment of children, adolescents and young adults with Intracranial Germ Cell Tumours

Summary:
Intracranial germ cell tumours (GCTs) are rare tumours of childhood and adolescence that are varied with respect to their primary site, histology, biological profile and response to treatment. This trial is attempting to distinguish these different tumours by virtue of these factors, and treat accordingly. The philosophy is that the worse the prognosis (in relative terms), the more aggressive the treatment needs to be. In malignant GCTs, initial combination platinumbased chemotherapy will be administered prior to risk adapted radiotherapy and delayed tumour resection where required. In tumours with mixed histology, the therapeutic approach depends on the component with the highest grade of malignancy. For teratoma, no standardized treatment approach has been investigated in a multinational protocol to date.

Inclusion criteria:
Note: Given the rarity of the disease and the aims of the trial, inclusion criteria are necessarily broad: Primary diagnosis of an intracranial germ cell tumour Main residence in one of the participating countries Written consent for trial participation, diagnosis and treatment according to the protocol and consent for data transfer

Exclusion criteria:
Primary diagnosis predating the opening of SIOP CNS GCT II Patients with CNS GCTs as second malignancies Patients in whom treatment according to CNS GCT II is not intended Patients with a medical, psychiatric or social condition incompatible with protocol treatment Participation within a different trial for treatment of germ cell tumours and/or concurrent treatment within any other clinical trial. The only exceptions to this are trials with different endpoints, involving aspects of supportive treatment which can run parallel to SIOP CNS GCT II without influencing the outcome of this trial e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support etc. Pregnancy and lactation Any treatment not given according to protocol prior to registration

Principal Investigator for this trial: Professor Richard Grundy

Research Ethics Committee Reference: 12/EE/0271

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

ION? Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patients

Summary:
Total thryroidectomy(surgery to remove the thyroid gland) followed by Radioactive Iodine Ablation is the standard treatment for patients presenting with intermediate or high risk well differentiated thyroid cancer. Radioiodine (RAI) is mainly used to eliminate any residual normal thyroid tissue. In a subgroup of patients characterised as having low risk of recurrence there is debate as to whether ablation represents overtreatment. RAI causes many side effects including increased risk of a second primary cancer. IoN will answer the question of whether RAI is necessary for low risk differentiated thyroid cancer patients who already have been offered the other two important modalities of treatment i.e. Total Thyroidectomy and optimal TSH (Thyroid Stimulating Hormone) suppression. Patients who have undergone a total thyroidectomy will be randomised (allocated randomly) into one of two groups by a computer program. One group will receive ablation at an activity of 1.1 GBq (Giga Becquerels), the other will not receive ablation. There will be an equal number of patients in both groups. The study is being funded by Cancer Research UK and has a phase II component to assess whether recruitment is feasible before moving to a phase III study. 570 patients will be recruited for the study.

Inclusion criteria:
1. R0 total thyroidectomy (in one or two stages, no residual disease present) within the last 6 months 2. Negative pregnancy test in women of child bearing potential 3. Aged 16 or over 4. WHO performance status 0 ­ 2, self caring 5. Histological confirmation of differentiated thyroid carcinoma: Papillary thyroid cancer a. Non aggressive histological features (small foci of aggressive histology allowed) b. pT1b (12cm), intrathyroidal c. pT2 (24cm), intrathyroidal d. pT3, intrathyroidal only e. Multifocal microcarcinoma f. pN0 g. pN1a h. pNX Follicular thyroid cancer/ Hürthle cell cancer (minimally invasive with capsular invasion only) a. pT1b (1 2cm), pT2 (24cm) intrathyroidal

Exclusion criteria:
1. Papillary and Follicular carcinoma which is unifocal and Principal Investigator for this trial: Dr Sally Ann Morgan

Research Ethics Committee Reference: 11/NE/0228

Contact us about participating in this study by emailing R&IActiveStudyEnquiries@nuh.nhs.uk or telephoning 0115 924 9924 Ext. 70076 Continue reading

Standard Operating Procedures

Please refer to this page frequently to ensure the correct SOP is used
To access templates and forms associated with individual SOPs please refer to Templates and Forms.
All links in this section are direct downloads for pdfs
R&I have reviewed … Continue reading

CLAHRC Briefing on Innovation, Health & Wealth

This CLAHRC NDL briefing concerns recent policy developments in Innovation Health & Wealth. Learn about important changes and plans in this easy to consume summary, together with links to the full details if you need to delve more deeply. This briefing outlines the eight priority areas for improvement and succinct descriptions of the High Impact Innovations which should be introduced with
immediate effect.
Continue reading

Jennie Walker

Jennie Walker
Academic Division of Orthopaedic and Accident Surgery
C floor West Block, Queen’s Medical Centre
0115 924 9924 ext 64170
Jennie.walker@nottingham.ac.uk or Jennie.walker@nuh.nhs.uk
Role
Clinical Educator (part time)
Teaching and assessment of medical undergraduates.
Teaching and professional development of nursing staff within MSKN.
Biography
Graduated from the University … Continue reading

How do I recruit patients and the public and keep them involved?

The Department of Research & Innovation has established a standard operational procedure ‘Recruiting patients and the public’. You may contact Jane Flewitt for additional advice.

This site uses cookies. Find out more about this site’s cookies.