Pilot study - Outlining the immune profile of ovarian cancer
Research type
Research Study
Full title
Pilot study - Outlining the immune profile of ovarian cancer
IRAS ID
173963
Contact name
Jonathan Ledermann
Contact email
Sponsor organisation
University College London (UCL)
Duration of Study in the UK
1 years, 4 months, 19 days
Research summary
Ovarian carcinoma is frequently diagnosed at advanced stages, and remains the disease with the highest mortality rate amongst gynaecological tumours. It is the fourth commonest cause of cancer death in women in the UK, with approximately 4,500 deaths each year. Surgery and chemotherapy are key elements of treatment. About half the patients with advanced disease will typically undergo pre-operative (neo-adjuvant) chemotherapy, followed by surgery and post-operative chemotherapy. The response rate to this is around 80%, with a median progression-free interval of 18 months. Therefore, there is a real need to develop new treatments that prevent disease recurrence and progression following first-line treatment in ovarian cancer.
There is growing evidence that immunomodulation of ovarian cancer provides a good basis for developing novel treatments. However, the immune profile of ovarian cancer is not well understood, nor how it might change under the influence of chemotherapy. We therefore propose a pilot study to investigate the immunological landscape of ovarian cancer, comparing immunological parameters at tissue diagnosis and at surgery after neoadjuvant chemotherapy. The results from this study will provide insight into possible targets and factors that might predict the response to immunotherapy.
This pilot study will recruit women who are thought to have a preliminary diagnosis of ovarian cancer unsuitable for upfront surgery, requiring neoadjuvant chemotherapy. As part of standard care, patients will require a biopsy for histological diagnosis, and will be approached for consent to obtain extra tissue (taken at the same time of biopsy), bloods and ascitic fluid (if drainage is clinically required). Patients who respond to chemotherapy and deemed surgically operable will proceed to optimal interval debulking surgery and then complete post-operative chemotherapy as per standard care. Tumour tissue from surgical specimen will also be consented for to be used as part of this study and stored for future research.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
15/WM/0322
Date of REC Opinion
11 Sep 2015
REC opinion
Further Information Favourable Opinion