here you go

Search Results

You searched for 'file note'. Your search returned 9 results.

An open label phase I/randomised, double blind phase II study in metastatic castration resistant Prostate Cancer of AZD5363 in combination with Docetaxel and prednisolone chemotherapy (ProCAID)

Summary:
Docetaxel and prednisolone chemotherapy (DP) is the only treatment proven to extend survival as first line
chemotherapy in metastatic castration resistant prostate cancer (mCRPC). Clinical benefit from DP is modest however and DP resistance is a common problem raising a pressing clinical need to build on the benefits of DP.
One approach to this is to develop a rational combination of docetaxel with a drug with likely clinical synergy and complimentary toxicity profile that might circumvent DP resistance. AKT (Protein Kinase B) activation is common in prostate cancer reaching up to 100% in metastatic disease. This contributes to disease progression and DP resistance.
AZD5363 is an orally available potent AKT inhibitor. The ProCAID trial will test the hypothesis that AZD5363 prolongs progression free survival when combined with DP for mCRPC.

Inclusion criteria:
1.Histologically or cytologically proven mCRPC with documented metastases (measurable or evaluable disease is acceptable) now eligible for treatment with docetaxel chemotherapy
2.Disease progression since the last change in therapy defined by one or more of the following according to the
Prostate Cancer Working Group (PCWG2) criteria (J Clin Oncol 2008;26:11481159):
i.PSA progression as defined by the prostate cancer working group (2) (PCWG2) criteria (Scher et al. 2008 J Clin Oncol. 26; 1148). This must be based on a series of at least 3 readings at least 7 days apart. The 3rd reading must be >= 2ng/ml. In the event where an intermediate reading is lower than a previous reading, then the patient will still be eligible (ie. the 3 readings do not need to be consecutive). The first of the three readings must have been obtained after commencing the previous systemic therapy, or, in the case of androgen receptor antagonists, after discontinuing.
ii.Radiographic progression of nodal or visceral metastases as defined by RECIST version 1.1 (Eur J Cancer 2009;45:228). See Appendix 5
iii.The appearance of two or more new bony metastases
3.Serum testosterone 3 months
12.Aged 18 years or over
13.Provision of written informed consent

Exclusion criteria:
1.Previous treatment with cytotoxic chemotherapy (patients may have received previous or ongoing bisphosphonates or denosumab). There are no restrictions on prior use of second generation hormonal therapies e.g. abiraterone,
enzalutamide
2.Prior malignancy with an estimated ≥ 30% chance of relapse within 2 years following curative treatment
3.Previously identified brain metastases, or spinal cord compression unless treated with full functional recovery
4.Prior radiotherapy to > 30% of bone marrow
5.Administration of an investigational agent within 30 days of first dose of study medication
6.Type I or II diabetes mellitus requiring either insulin or oral hypoglycaemics for routine management. Patients with type II diabetes mellitus that is well controlled by dietary measures alone are eligible to participate. Patients found to have a fasting glucose ≥7 mmol/L (≥126 mg/dL) or glycosylated haemoglobin >8% (64 mmol/mol) at screening should be assessed for appropriate management according to local policy. Those in whom dietary measures alone provide
good diabetic control will be eligible for inclusion
7.Malabsorption syndrome, previous gastrointestinal surgery, or other gastrointestinal condition that may affect drug absorption
8.Coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris or congestive heart failure (NYHA ≥ grade 2) within the last 6 months
9.Abnormal echocardiogram (LVEF 480 msec at two or more time points within a 24 hour period
12.Proteinuria (3+ on dipstick analysis or >500 mg/24 hours) or creatinine >1.5 x ULN concurrent with creatinine clearance 500 mg/24 hours) or creatinine >1.5 x ULN concurrent with creatinine clearance Principal Investigator for this trial: Dr Santhanam Sundar

Research Ethics Committee Reference: 13/LO/1691

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

An open label phase I/randomised, double blind phase II study in metastatic castration resistant Prostate Cancer of AZD5363 in combination with Docetaxel and prednisolone chemotherapy (ProCAID)

Summary:
Docetaxel and prednisolone chemotherapy (DP) is the only treatment proven to extend survival as first line
chemotherapy in metastatic castration resistant prostate cancer (mCRPC). Clinical benefit from DP is modest however and DP resistance is a common problem raising a pressing clinical need to build on the benefits of DP.
One approach to this is to develop a rational combination of docetaxel with a drug with likely clinical synergy and complimentary toxicity profile that might circumvent DP resistance. AKT (Protein Kinase B) activation is common in prostate cancer reaching up to 100% in metastatic disease. This contributes to disease progression and DP resistance.
AZD5363 is an orally available potent AKT inhibitor. The ProCAID trial will test the hypothesis that AZD5363 prolongs progression free survival when combined with DP for mCRPC.

Inclusion criteria:
1.Histologically or cytologically proven mCRPC with documented metastases (measurable or evaluable disease is acceptable) now eligible for treatment with docetaxel chemotherapy
2.Disease progression since the last change in therapy defined by one or more of the following according to the
Prostate Cancer Working Group (PCWG2) criteria (J Clin Oncol 2008;26:11481159):
i.PSA progression as defined by the prostate cancer working group (2) (PCWG2) criteria (Scher et al. 2008 J Clin Oncol. 26; 1148). This must be based on a series of at least 3 readings at least 7 days apart. The 3rd reading must be >= 2ng/ml. In the event where an intermediate reading is lower than a previous reading, then the patient will still be eligible (ie. the 3 readings do not need to be consecutive). The first of the three readings must have been obtained after commencing the previous systemic therapy, or, in the case of androgen receptor antagonists, after discontinuing.
ii.Radiographic progression of nodal or visceral metastases as defined by RECIST version 1.1 (Eur J Cancer 2009;45:228). See Appendix 5
iii.The appearance of two or more new bony metastases
3.Serum testosterone 3 months
12.Aged 18 years or over
13.Provision of written informed consent

Exclusion criteria:
1.Previous treatment with cytotoxic chemotherapy (patients may have received previous or ongoing bisphosphonates or denosumab). There are no restrictions on prior use of second generation hormonal therapies e.g. abiraterone,
enzalutamide
2.Prior malignancy with an estimated ≥ 30% chance of relapse within 2 years following curative treatment
3.Previously identified brain metastases, or spinal cord compression unless treated with full functional recovery
4.Prior radiotherapy to > 30% of bone marrow
5.Administration of an investigational agent within 30 days of first dose of study medication
6.Type I or II diabetes mellitus requiring either insulin or oral hypoglycaemics for routine management. Patients with type II diabetes mellitus that is well controlled by dietary measures alone are eligible to participate. Patients found to have a fasting glucose ≥7 mmol/L (≥126 mg/dL) or glycosylated haemoglobin >8% (64 mmol/mol) at screening should be assessed for appropriate management according to local policy. Those in whom dietary measures alone provide
good diabetic control will be eligible for inclusion
7.Malabsorption syndrome, previous gastrointestinal surgery, or other gastrointestinal condition that may affect drug absorption
8.Coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris or congestive heart failure (NYHA ≥ grade 2) within the last 6 months
9.Abnormal echocardiogram (LVEF 480 msec at two or more time points within a 24 hour period
12.Proteinuria (3+ on dipstick analysis or >500 mg/24 hours) or creatinine >1.5 x ULN concurrent with creatinine clearance 500 mg/24 hours) or creatinine >1.5 x ULN concurrent with creatinine clearance Principal Investigator for this trial: Dr Santhanam Sundar

Research Ethics Committee Reference: 13/LO/1691

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

Adults with acute myeloid leukaemia or high-risk myelodysplastic syndrome

Summary:
AML19 will build upon the results of previous trials in acute myeloid leukaemia. It will evaluate several relevant therapeutic questions in patients who are 18-60
years old and suitable for intensive chemotherapy. For patients who do not have the APL subtype, the investigators will evaluate the best way of adding mylotarg to induction chemotherapy. After induction, patients will be characterised based upon their prognosis and may enter different randomisations the
randomisations allow patients to access different treatments based on their disease profile. The investigators will also evaluate whether continued monitoring of patients can improve outcomes and affects quality of life. Patients with the APL subtype will enter a different part of the trial.

Inclusion criteria:
Patients are eligible for the AML19 trial if:
• They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification (Appendix A) — this can be any type of de novo or secondary AML or high risk Myelodysplastic Syndrome (defined as >10% bone marrow blasts)
• Patients with acute promyelocytic leukaemia (APL) are eligible and should be entered into the randomisations
specifically for APL (see Section 9).
• They are considered suitable for intensive chemotherapy.
• They should normally be 18 years up to the age of 60, but patients over this age are eligible if intensive therapy is considered a suitable option.
• The Serum creatinine should be ≤ 1.5 × ULN (upper limit of normal)
• Patients eligible for the Mylotarg randomisation must have Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5 ×ULN and bilirubin ≤2.×ULN (Note: Patients who do not comply with the liver inclusion criteria are eligible to enter the trial but will be excluded from the Mylotarg randomisation)
• A negative pregnancy test within 2 weeks prior to trial entry in WOCBP to be repeated throughout the trial prior to each course of protocol treatment
• Sexually mature males must agree to use an adequate and medically accepted method of contraception throughout the study if their sexual partners are women of child bearing potential (WOCBP). Similarly women must agree to highly effective contraceptive measures (See Appendix J). This applies to APL and AML patients. In both males and females these measures must be in place for at least 30 days after the last administration of all IMPs.
• They have given written informed consent

APL Patients
• They have provided signed written informed consent (PIS 3)
• They have a morphological diagnosis of APL (if cytogenetic or molecular diagnosis is not confirmed patients will transfer to the non-APL treatments)
• They should be over 18 years.
• They have WHO performance status 02
• Their Serum total bilirubin is Exclusion criteria:
AML
Patients are not eligible for the AML arms of the AML19 trial if:
• They have previously received cytotoxic chemotherapy for AML. [Hydroxycarbamide, or similar low-dose
therapy, to control the white count prior to initiation of intensive therapy is not an exclusion.]
• They have received demethylation therapy for AML or high risk MDS defined as marrow blasts >10%. Patients treated for lower risk MDS who progress to AML are eligible.
• They are in blast transformation of chronic myeloid leukaemia (CML).
• They have a concurrent active malignancy requiring treatment.
• They are pregnant or lactating.
• The physician and patient consider that intensive therapy is not an appropriate treatment option.
• Known infection with Human Immunodeficiency Virus (HIV).
• Patients with AST or ALT more than 2.5 times the local upper limit of normal or Bilirubin more than twice upper limit of normal, are not eligible for the Mylotarg randomisations.
For Ganetespib randomisation there are specific cardiac exclusions:
• A myocardial infarction within 12 months
• Uncontrolled angina within 6 months
• Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless an
echocardiogram (ECHO) or Multiple Gated Acquisition Scan (MUGA) performed either within 1 month prior to study screening or during screening results in a left ventricular ejection fraction (LVEF) that is ≥ 45% (or institutional lower limit of normal value).
• Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes [TdP]) or any history of arrhythmia will be discussed with the Clinical Coordinator/Safety Physician prior to patient’s entry into the study.
• Prolonged QTcF interval on pre-entry ECG (≥450 ms)
• Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker
• Heart rate Principal Investigator for this trial: Professor Nigel Russell

Research Ethics Committee Reference: 14/WA/1056

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

Adults with acute myeloid leukaemia or high-risk myelodysplastic syndrome

Summary:
AML19 will build upon the results of previous trials in acute myeloid leukaemia. It will evaluate several relevant therapeutic questions in patients who are 18-60
years old and suitable for intensive chemotherapy. For patients who do not have the APL subtype, the investigators will evaluate the best way of adding mylotarg to induction chemotherapy. After induction, patients will be characterised based upon their prognosis and may enter different randomisations the
randomisations allow patients to access different treatments based on their disease profile. The investigators will also evaluate whether continued monitoring of patients can improve outcomes and affects quality of life. Patients with the APL subtype will enter a different part of the trial.

Inclusion criteria:
Patients are eligible for the AML19 trial if:
• They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification (Appendix A) — this can be any type of de novo or secondary AML or high risk Myelodysplastic Syndrome (defined as >10% bone marrow blasts)
• Patients with acute promyelocytic leukaemia (APL) are eligible and should be entered into the randomisations
specifically for APL (see Section 9).
• They are considered suitable for intensive chemotherapy.
• They should normally be 18 years up to the age of 60, but patients over this age are eligible if intensive therapy is considered a suitable option.
• The Serum creatinine should be ≤ 1.5 × ULN (upper limit of normal)
• Patients eligible for the Mylotarg randomisation must have Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5 ×ULN and bilirubin ≤2.×ULN (Note: Patients who do not comply with the liver inclusion criteria are eligible to enter the trial but will be excluded from the Mylotarg randomisation)
• A negative pregnancy test within 2 weeks prior to trial entry in WOCBP to be repeated throughout the trial prior to each course of protocol treatment
• Sexually mature males must agree to use an adequate and medically accepted method of contraception throughout the study if their sexual partners are women of child bearing potential (WOCBP). Similarly women must agree to highly effective contraceptive measures (See Appendix J). This applies to APL and AML patients. In both males and females these measures must be in place for at least 30 days after the last administration of all IMPs.
• They have given written informed consent

APL Patients
• They have provided signed written informed consent (PIS 3)
• They have a morphological diagnosis of APL (if cytogenetic or molecular diagnosis is not confirmed patients will transfer to the non-APL treatments)
• They should be over 18 years.
• They have WHO performance status 02
• Their Serum total bilirubin is Exclusion criteria:
AML
Patients are not eligible for the AML arms of the AML19 trial if:
• They have previously received cytotoxic chemotherapy for AML. [Hydroxycarbamide, or similar low-dose
therapy, to control the white count prior to initiation of intensive therapy is not an exclusion.]
• They have received demethylation therapy for AML or high risk MDS defined as marrow blasts >10%. Patients treated for lower risk MDS who progress to AML are eligible.
• They are in blast transformation of chronic myeloid leukaemia (CML).
• They have a concurrent active malignancy requiring treatment.
• They are pregnant or lactating.
• The physician and patient consider that intensive therapy is not an appropriate treatment option.
• Known infection with Human Immunodeficiency Virus (HIV).
• Patients with AST or ALT more than 2.5 times the local upper limit of normal or Bilirubin more than twice upper limit of normal, are not eligible for the Mylotarg randomisations.
For Ganetespib randomisation there are specific cardiac exclusions:
• A myocardial infarction within 12 months
• Uncontrolled angina within 6 months
• Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless an
echocardiogram (ECHO) or Multiple Gated Acquisition Scan (MUGA) performed either within 1 month prior to study screening or during screening results in a left ventricular ejection fraction (LVEF) that is ≥ 45% (or institutional lower limit of normal value).
• Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes [TdP]) or any history of arrhythmia will be discussed with the Clinical Coordinator/Safety Physician prior to patient’s entry into the study.
• Prolonged QTcF interval on pre-entry ECG (≥450 ms)
• Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker
• Heart rate Principal Investigator for this trial: Professor Nigel Russell

Research Ethics Committee Reference: 14/WA/1056

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

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

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

MAGIC STUDY: MOLECULAR GENETICS OF ADVERSE DRUG REACTIONS (ADRs) IN CHILDREN

Summary:
Adverse drug reactions occur in children as well as adults, although in paediatrics there is a lack of definitive data. The range of potential ADRs that can affect children potentially includes the full range of ADRs that afflict adults, as well as ADRs that are paediatric specific, or occur at greater frequency in this population. In adult and paediatric populations, ADRs can be divided into two basic types: type A and type B: · Type A: dosedependent toxicities predictable from the known pharmacology of the drug and alleviated by either dose reduction or drug withdrawal and · Type B: doseindependent toxicities that are unpredictable from the known pharmacology of the drug (idiosyncratic), and usually require drug withdrawal for resolution. The factors predisposing individuals to ADRs with individual drugs are in most cases unknown. Genetic factors have long been postulated to be important in predisposing to both types of reactions, with the degree and type of genetic predisposition varying according to the type of reaction. Although type B reactions are proportionately more severe than type A reactions, it is important to note that type A reactions can also be severe. There is believed to be a genetic component to an individual child’s susceptibility to, and the severity of, ADRs. This genetic contribution is likely to vary with the drug, ethnic group, age, and the clinical phenotype of the adverse reaction. The hypothesis we are testing is that there are genetic factors that can affect an individual childs chance of getting specific ADRs. By analysing the DNA of children who have suffered an ADR we hope to be able to determine genetic risk factors (either single genes or combinations of genes) that could be tested prior to the commencement of certain therapies (or combinations of therapies), to assist clinicians in improving risk/benefit profiles for individual patients.

Inclusion criteria:
Case: Participant age 16 years at time of recruitment) or from parent/guardian (if 16 at time of recruitment) or parent/guardian (if age 16 years at time of recruitment) or from parent/guardian (if Exclusion criteria:
 Parent/guardian unwilling to take part (if participant 16 years at time of recruitment) Competent older participant unwilling to assent (competence assessed on a case by case basis) Patient is, in the opinion of the Investigator, not suitable to participate in the study.

Principal Investigator for this trial: Dr Jon Jin Kim

Research Ethics Committee Reference: 10/H1002/57

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

MAGIC STUDY: MOLECULAR GENETICS OF ADVERSE DRUG REACTIONS (ADRs) IN CHILDREN

Summary:
Adverse drug reactions occur in children as well as adults, although in paediatrics there is a lack of definitive data. The range of potential ADRs that can affect children potentially includes the full range of ADRs that afflict adults, as well as ADRs that are paediatric specific, or occur at greater frequency in this population. In adult and paediatric populations, ADRs can be divided into two basic types: type A and type B: · Type A: dosedependent toxicities predictable from the known pharmacology of the drug and alleviated by either dose reduction or drug withdrawal and · Type B: doseindependent toxicities that are unpredictable from the known pharmacology of the drug (idiosyncratic), and usually require drug withdrawal for resolution. The factors predisposing individuals to ADRs with individual drugs are in most cases unknown. Genetic factors have long been postulated to be important in predisposing to both types of reactions, with the degree and type of genetic predisposition varying according to the type of reaction. Although type B reactions are proportionately more severe than type A reactions, it is important to note that type A reactions can also be severe. There is believed to be a genetic component to an individual child’s susceptibility to, and the severity of, ADRs. This genetic contribution is likely to vary with the drug, ethnic group, age, and the clinical phenotype of the adverse reaction. The hypothesis we are testing is that there are genetic factors that can affect an individual childs chance of getting specific ADRs. By analysing the DNA of children who have suffered an ADR we hope to be able to determine genetic risk factors (either single genes or combinations of genes) that could be tested prior to the commencement of certain therapies (or combinations of therapies), to assist clinicians in improving risk/benefit profiles for individual patients.

Inclusion criteria:
Case: Participant age 16 years at time of recruitment) or from parent/guardian (if 16 at time of recruitment) or parent/guardian (if age 16 years at time of recruitment) or from parent/guardian (if Exclusion criteria:
 Parent/guardian unwilling to take part (if participant 16 years at time of recruitment) Competent older participant unwilling to assent (competence assessed on a case by case basis) Patient is, in the opinion of the Investigator, not suitable to participate in the study.

Principal Investigator for this trial: Professor Harish Vyas

Research Ethics Committee Reference: 10/H1002/51

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

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