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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

Vacancy: Research Contracts Manager, applications close 23rd June

NUH Research & Innovation is looking for a Research Contracts Manager with expert knowledge of clinical research, relevant legislation, contract and intellectual property law to join our team at the Trust. Continue reading

Vacancy: Research Contracts Assistant, applications close 5th December

This full time post will support our Research Contracts Manager in providing legal advice to the Trust by facilitating, reviewing and amending as required a wide range of agreements connected to biomedical research carried out at NUH. Continue reading

Head of IP and Contracts vacancy at NUH R&I, closing date for applicants 22nd Jan 2012

Do you wish to make a difference to clinical research and intellectual property management in the NHS? As the volume of research and innovation supported by NUH increases, as Head of IP and Contracts you will provide the legal services which NUH requires in the research related fields of intellectual property, commercial, competition, governance and corporate law. Continue reading

Commercial Research at NUH

The introduction of the HRA and central governance review has caused some changes in the way in which commercial clinical trials are set up at our site. The below guidance is to help Sponsors ensure that set up of these … Continue reading

A randomized phase III trial comparing radical hysterectomy and pelvic node dissection versus simple hysterectomy and pelvic node dissection in patients with low­risk early­stage cervical cancer (SHAPE)

Summary:
Cervical cancer is the second most common worldwide cause of female cancer deaths. In the UK in 2010, there were 3500 cases and 940 deaths. Screening has reduced the incidence in the UK but the proportion of young women presenting with low-risk early stage disease has increased. The current standard of care for these patients is a radical hysterectomy with pelvic lymph node dissection, the cure rate is high but women are at risk of suffering “survivorship” issues related to long term surgical effects such as compromised sexual, bowel and bladder function, as well as infertility. It is unclear whether less radical surgery, which has a lower morbidity is as effective, as well as there being a lack of high-quality evidence upon which clinicians can base their decisions and advise their patients. The answers to these questions will be determined by a randomised international trial. The SHAPE trial will address
whether a simple hysterectomy with pelvic node dissection in patients with previously untreated, low-risk,
early-stage cervical cancer is of similar benefit to a radical hysterectomy with pelvic node dissection with respect to preventing the cancer returning. The definition of early-stage, low-risk cervical cancer is based on the International Federation of Gynaecology and Obstetrics (FIGO) staging classification schema, and includes early stage IA2 patients and a subset of those with stage IB1 disease (cervical cancer confined to within the cervix). Secondary endpoints include extra pelvic relapse-free survival, overall survival, toxicity and patient reported outcomes. The latter endpoint is of particular importance, therefore survivorship issues with regards to quality of life and sexual function will be addressed given the short and long term side effects associated with a radical hysterectomy. Health economics will also be evaluated given that a simple hysterectomy should be associated with fewer postoperative and long-term management requirements.

Inclusion criteria:
1) Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix. Diagnosis has
been made by LEEP, cone or cervical biopsy and has been reviewed and confirmed by the local reference
gynaecological pathologist.
2) Patient has been classified as low-risk
early-stage cervical cancer. These patients include:
FIGO Stage 1A2 [FIGO Annual Report, 2009], defined as:
a) evidence of disease by microscopy;
– histologic evidence of depth of stromal invasion between 3.0-5.0 mm based on the local reference pathologist’s measurement of the LEEP or cone specimen (for patient who underwent a LEEP or cone);
– histologic evidence of lateral extension that is not greater than 7.0 mm based on the local reference pathologist’s measurement of the LEEP or cone specimen (for patient who underwent a LEEP or cone); and
– negative margins (for patients who underwent a LEEP or cone)
– radiologic evidence of less than 50% stromal invasion based on pelvic MRI (for patients who underwent a cervical biopsy only)
b) b)FIGO Stage 1B1 [FIGO Annual Report, 2009] with favorable (low risk) features, defined as:
– a clinically visible lesion or a microscopically diagnosed lesion measuring > 5 mm depth of invasion or > 7 mm in lateral extension or a IA2 sized lesion with positive margins;
– histologic evidence of less than 10mm stromal invasion based on the local reference pathologist’s measurement
of the LEEP or cone specimen Note: this criterion will not apply to patients who underwent a cervical biopsy only;
– Radiologic evidence of maximum dimension of ≤ 20 mm as seen by pelvic MRI; and
– Radiologic evidence of less than 50% stromal invasion based on pelvic MRI.
3) The histologic grade of cervical cancer must be 1, 2, 3 or not assessable
4) Physical examination, recto-vaginal examination and visualization of the cervix by speculum or colposcopic examination have been done after the initial diagnosis procedure (LEEP, cone or biopsy) and prior to randomisation. Staging criteria described in 2 above must be satisfied based on these examinations.
5) Chest XRay or CT scan of the chest AND pelvic MRI (pelvic MRI is optional if the patient has stage 1A2 disease and underwent and LEEP or cone) done after initial diagnostic procedure (LEEP, cone or biopsy) and prior to randomisation. Staging criteria described in 2 above must be satisfied based on these examinations.
The CT should be a 16 slice (or higher) helical scanner. Oral and intravenous contracts are preferred (unless there is a contraindication to the use of contrast) with scan obtained in the portal phase at a slice thickness of 5mm or lower.
Pelvic MRI should be performed on a 1.5 or 3 Tesla magnet with pelvic phasedarray coils. The MR pulse sequences will consist of T1 gradient echo in the axial plane at 5mm slice thickness and fast spin echo in the axial, sagittal, and coronal planes at 4mm slice thickness. The short axis (perpendicular to the tumour’s long axis) with a 3mm slice thickness is required in the best plane to show the maximum thickness of stromal invasion. Use of an antiperistaltic agent is mandatory while intravenous use of gadolinium or diffusion-weighted imaging (DWI) is optional.
6) After consideration of a patient’s medical history, physical examination and laboratory testing, patients must be suitable candidates for surgery as defined by the attending physician / investigator.
7) Patients must have no desire to preserve fertility.
8) Patients must be willing to complete the Quality of Life Questionnaire. The baseline assessments must be
completed within 6 weeks prior to randomisation. Inability (illiteracy in English, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible. Patients fluent in English or French who reside in Canada and the United Kingdom must agree to participate in the economic evaluation component of this trial and complete the Health Economics Questionnaires.
9) Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
10) Patient must be accessible for treatment and follow up. Investigator must assure themselves the patients
randomised on this trial will be available for complete documentation of the treatment, adverse events and follow up.
11) Surgery is to be done within 20 weeks of initial diagnosis (no exceptions). The 20 week period includes time required for diagnosis, referral, diagnostic staging, randomisation and scheduling of the surgical procedure.
12) Patients must be 18 years or older.

Exclusion criteria:
1) Patients with FIGO 1A1 disease
2) History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours, Hodgkin’s lymphoma or non-Hodgkin’s lymphoma curatively treated with no evidence of disease for >5 years
3) Patients with evidence of lymph node metastasis on preoperative imaging or histology
4) Patients who have had or will receive neoadjuvant chemotherapy
5) Patients who are pregnant

Principal Investigator for this trial: Miss Karin Williamson

Research Ethics Committee Reference: 14/YH/1108

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

A randomized phase III trial comparing radical hysterectomy and pelvic node dissection versus simple hysterectomy and pelvic node dissection in patients with low­risk early­stage cervical cancer (SHAPE)

Summary:
Cervical cancer is the second most common worldwide cause of female cancer deaths. In the UK in 2010, there were 3500 cases and 940 deaths. Screening has reduced the incidence in the UK but the proportion of young women presenting with low-risk early stage disease has increased. The current standard of care for these patients is a radical hysterectomy with pelvic lymph node dissection, the cure rate is high but women are at risk of suffering “survivorship” issues related to long term surgical effects such as compromised sexual, bowel and bladder function, as well as infertility. It is unclear whether less radical surgery, which has a lower morbidity is as effective, as well as there being a lack of high-quality evidence upon which clinicians can base their decisions and advise their patients. The answers to these questions will be determined by a randomised international trial. The SHAPE trial will address
whether a simple hysterectomy with pelvic node dissection in patients with previously untreated, low-risk,
early-stage cervical cancer is of similar benefit to a radical hysterectomy with pelvic node dissection with respect to preventing the cancer returning. The definition of early-stage, low-risk cervical cancer is based on the International Federation of Gynaecology and Obstetrics (FIGO) staging classification schema, and includes early stage IA2 patients and a subset of those with stage IB1 disease (cervical cancer confined to within the cervix). Secondary endpoints include extra pelvic relapse-free survival, overall survival, toxicity and patient reported outcomes. The latter endpoint is of particular importance, therefore survivorship issues with regards to quality of life and sexual function will be addressed given the short and long term side effects associated with a radical hysterectomy. Health economics will also be evaluated given that a simple hysterectomy should be associated with fewer postoperative and long-term management requirements.

Inclusion criteria:
1) Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix. Diagnosis has
been made by LEEP, cone or cervical biopsy and has been reviewed and confirmed by the local reference
gynaecological pathologist.
2) Patient has been classified as low-risk
early-stage cervical cancer. These patients include:
FIGO Stage 1A2 [FIGO Annual Report, 2009], defined as:
a) evidence of disease by microscopy;
– histologic evidence of depth of stromal invasion between 3.0-5.0 mm based on the local reference pathologist’s measurement of the LEEP or cone specimen (for patient who underwent a LEEP or cone);
– histologic evidence of lateral extension that is not greater than 7.0 mm based on the local reference pathologist’s measurement of the LEEP or cone specimen (for patient who underwent a LEEP or cone); and
– negative margins (for patients who underwent a LEEP or cone)
– radiologic evidence of less than 50% stromal invasion based on pelvic MRI (for patients who underwent a cervical biopsy only)
b) b)FIGO Stage 1B1 [FIGO Annual Report, 2009] with favorable (low risk) features, defined as:
– a clinically visible lesion or a microscopically diagnosed lesion measuring > 5 mm depth of invasion or > 7 mm in lateral extension or a IA2 sized lesion with positive margins;
– histologic evidence of less than 10mm stromal invasion based on the local reference pathologist’s measurement
of the LEEP or cone specimen Note: this criterion will not apply to patients who underwent a cervical biopsy only;
– Radiologic evidence of maximum dimension of ≤ 20 mm as seen by pelvic MRI; and
– Radiologic evidence of less than 50% stromal invasion based on pelvic MRI.
3) The histologic grade of cervical cancer must be 1, 2, 3 or not assessable
4) Physical examination, recto-vaginal examination and visualization of the cervix by speculum or colposcopic examination have been done after the initial diagnosis procedure (LEEP, cone or biopsy) and prior to randomisation. Staging criteria described in 2 above must be satisfied based on these examinations.
5) Chest XRay or CT scan of the chest AND pelvic MRI (pelvic MRI is optional if the patient has stage 1A2 disease and underwent and LEEP or cone) done after initial diagnostic procedure (LEEP, cone or biopsy) and prior to randomisation. Staging criteria described in 2 above must be satisfied based on these examinations.
The CT should be a 16 slice (or higher) helical scanner. Oral and intravenous contracts are preferred (unless there is a contraindication to the use of contrast) with scan obtained in the portal phase at a slice thickness of 5mm or lower.
Pelvic MRI should be performed on a 1.5 or 3 Tesla magnet with pelvic phasedarray coils. The MR pulse sequences will consist of T1 gradient echo in the axial plane at 5mm slice thickness and fast spin echo in the axial, sagittal, and coronal planes at 4mm slice thickness. The short axis (perpendicular to the tumour’s long axis) with a 3mm slice thickness is required in the best plane to show the maximum thickness of stromal invasion. Use of an antiperistaltic agent is mandatory while intravenous use of gadolinium or diffusion-weighted imaging (DWI) is optional.
6) After consideration of a patient’s medical history, physical examination and laboratory testing, patients must be suitable candidates for surgery as defined by the attending physician / investigator.
7) Patients must have no desire to preserve fertility.
8) Patients must be willing to complete the Quality of Life Questionnaire. The baseline assessments must be
completed within 6 weeks prior to randomisation. Inability (illiteracy in English, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible. Patients fluent in English or French who reside in Canada and the United Kingdom must agree to participate in the economic evaluation component of this trial and complete the Health Economics Questionnaires.
9) Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
10) Patient must be accessible for treatment and follow up. Investigator must assure themselves the patients
randomised on this trial will be available for complete documentation of the treatment, adverse events and follow up.
11) Surgery is to be done within 20 weeks of initial diagnosis (no exceptions). The 20 week period includes time required for diagnosis, referral, diagnostic staging, randomisation and scheduling of the surgical procedure.
12) Patients must be 18 years or older.

Exclusion criteria:
1) Patients with FIGO 1A1 disease
2) History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours, Hodgkin’s lymphoma or non-Hodgkin’s lymphoma curatively treated with no evidence of disease for >5 years
3) Patients with evidence of lymph node metastasis on preoperative imaging or histology
4) Patients who have had or will receive neoadjuvant chemotherapy
5) Patients who are pregnant

Principal Investigator for this trial: Miss Karin Williamson

Research Ethics Committee Reference: 14/YH/1108

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

NUH Research Award Management Services

If you are making an application for research grant funding you will need access to the NUH Research Award Management Service available as part of the business unit in R&I.
The experienced team can support you in:

Identifying appropriate funding streams … Continue reading

R&I Contact Details

Contact information for the Research and Innovation team is detailed below.
Our postal address is:
Research & Innovation
Nottingham University Hospitals NHS Trust
Nottingham Integrated Clinical Research Centre
C Floor, South Block
Queen’s Medical Centre Campus
Derby Road Nottingham NG7 2UH
For general enquiries please email … Continue reading

Post Award Support Service – Successful Research Grant Funding Applications

When your grant is awarded or you receive notification that it has been favourably considered by the awarding body there is a post award team within Research & Innovation ready to assist you in the process of managing the responsibilities … Continue reading

Intellectual Property Management

Nottingham University Hospitals NHS Trust recognises that its staff, from any discipline or sector, can be innovative, generate new ideas and find solutions to problems which given the opportunity, lead to improvements in the delivery of healthcare.
We are here to … Continue reading

Translational Research Partnerships

The NIHR Translational Research Partnerships (TRPs) were established in 2010 to pool elite clinicians and academics from 36 NHS organisations and universities into a central collaborating body driving translational research supported by NIHR clinical research infrastructure.
Each centre comprises at least … Continue reading

New local hosts announced for NIHR Clinical Research Network

The Department of Health, through the National Institute for Health Research (NIHR), has announced the 15 NHS Trusts/Foundation Trusts that will host the local branches of the NIHR Clinical Research Network from April 2014.

Research Passports

What is a Research Passport?
The Research Passport System is a process for issuing Honorary Research Contracts or letters of access to researchers who are carrying out research in the NHS.
Why do I need a Research Passport?
If you are carrying … Continue reading

Wendy Fisher explains the key concepts of the London Harmonisation project

Wendy Fisher and Nick Lemoine provide a comprehensive presentation of the Central and East London Harmonisation project. The project is aimed at reducing approval times for commercial studies by centralising the costing and contracts negotiations across partners.

Neovascular Macular Degeneration Tandem Trial opens to recruitment and publishes first newsletter

Following the trial’s suspension in November 2011, the trial co-ordination centre has relocated to the Nottingham Clinical Trials Unit and is recruiting again. Tandem is a randomised controlled trial of standard and low dose Avastin® for nevascular macular degeneration in … 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

Plan for Growth healthcare research update in Chancellor’s Autumn Statement

The Chancellor’s Autumn Statement includes a report on progress achieved with the measures contained in the March 2011 Plan for Growth. We’ve reproduced here all the 16 paragraphs that relate to Healthcare and Life Sciences. Continue reading

NIHR Research Support Services Framework Adopted for Immediate Use

The NIHR has adopted the Research Support Services Framework for immediate use. It will enable NHS R&D offices to offer a consistent, streamlined and risk-proportionate service to support research in the NHS in England. This follows the publication in March 2011 of the Government’s Plan for Growth, where the NIHR Research Support Services were first announced. Continue reading

PPI/E Frequently Asked Questions

Below are some of the frequently asked questions regarding Patient and Public Involvement in Research. If the answer to your query is not addressed then please contact our PPI leads:
Andy Wragg, covering National Digestive Diseases Centre Biomedical Research Unit
Vikki Develin, … Continue reading

Do you need ethics approval to involve users in research?

You do not need ethical approval to involve patients and the public as advisers for your research, for example if they help develop a questionnaire or patient information sheets.
However, if patients and the public are actively involved in undertaking the … Continue reading

R&I Team Profiles

Dr Steve Ryder
Director of Research
Since June 1994 Dr Ryder has been a consultant Physician in Hepatology and Gastroenterology at the Nottingham Digestive Diseases Centre and Biomedical Research Unit. His major clinical and research interest is hepatitis C infection.
Dr Ryder … Continue reading

Model Agreements

Model Agreements
Nationally approved standard Agreements help speed up the contracting process for industry-sponsored trials carried out in the NHS by removing the need for site-by-site reviews and local legal agreements to be drawn up. This enables trials to start … Continue reading

Application and Costing of NIHR Research Grant Bids

Types of NIHR grants
A. Programme Grants
Programme Grants for Applied Research are prestigious awards of up to £2m over a period of three to five years.
The aim is to provide evidence to improve health outcomes in England through promotion of … Continue reading

Biomedical Research Units

Nottingham is home to two Biomedical Research Units (BRUs) awarded by the Department of Health. BRUs represent a large scale investment in infrastructure and promote a strong partnership between the NHS, academia and industry partners. This success have identified the … Continue reading

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