The Leeds Teaching Hospitals NHS Trust

Industrial partnership for new drug development for the treatment of ovarian cancer

2 May 2019

Ovarian cancer is the second commonest gynaecological malignancy in the UK and resulted 4,128 deaths per year in 2014. This cancer is rarely diagnosed until it is advanced, when successful treatment is less likely. Surgery and chemotherapy are the mainstay of treatment but cure in advanced disease is uncommon. There is therefore a need to develop new, more effective therapies.

While universities and other research centres play a key role in improving our understanding of cancer biology, large pharmaceutical companies are responsible for the development of new anti-cancer drugs. One of the difficulties they face is access to cancer specimens with associated patient data (e.g. the type of cancer, the treatment patients received and whether this was successful) held by NHS hospitals. The aim of this project at St James’s University Hospital is to provide these to support the development of new drugs.

This project is funded by TriStar, a US-based contract research that works with various NHS centres to access cancer specimens. TriStar works in partnership with pharmaceutical companies to support their development of new cancer tests and treatments. Although TriStar is covering the costs of NHS staff involved in cancer specimen and data collection, these samples will not be ‘used for financial gain’ or ‘sold to a third party’ by the NHS.

This project involves collecting 500 historical cases of ovarian cancer cases held in the Leeds Teaching Hospitals histopathology archives. Cancer cases will be identified from clinical records, and both samples and clinical (not personal) data will be transferred to TriStar. Accessing patient records is required to collect information about disease and response to treatment, but all data will be anonymised before being sent to TriStar (i.e. it will be not be possible to identify patients from the data). Subsequent investigations on the specimens will vary depending on the pharmaceutical company’s drug development programme(s). Sample/data collection will have no impact on patient care, present or future. It will however make best use of historical cancer specimens, which would otherwise be kept for 30 years before being destroyed with no benefit to patients. Importantly, it will benefit future patients by supporting successful drug development.

There is also an academic research benefit to this project. Half of all the cancer specimens processed by TriStar will be returned to Leeds (at TriStar’s expense). These will then be made available to scientists and doctors at the University of Leeds/Leeds Teaching Hospitals Trust and boost ovarian cancer research, both at Leeds and internationally.

Patients will not be asked for permission to access their records since this project is based on old, historical cases. Many of these patients will unfortunately have passed away or moved home. However, we recognise that some patients will still be alive and may be unwilling to have their cancer material or data used for research.

Therefore, we invite anyone who would like to know more about this project or who would wish to ensure that their records are not accessed for research to contact us by 13th May 2019, when the project will start. This will enable us to keep a register of names to prevent these cases from being used. After the start of the project, it will still be possible for us to trace specimens before they are sent to TriStar, so we encourage anyone wishing to contact us by 5th August 2019. These cases can then be excluded from the study too.

The project has been approved by a Patient & Public Involvement Group, a Research Ethics Committee and the Health Research Authority at the recommendation of the Confidentiality Advisory Group, and is fully compliant with UK law.

For enquiries and further details, please contact the Chief Investigator:

Dr Nic Orsi

Clinical Lecturer in Histopathology

Leeds Institute of Cancer & Pathology

Wellcome Trust Brenner Building

St James’s University Hospital

Beckett Street

Leeds LS9 7TF

Tel: 0113 3438625