PROMISE Feasibility Study
Research type
Research Study
Full title
Predicting Risk of Ovarian Malignancy Improved Screening and Early Detection Feasibility Study
IRAS ID
208219
Contact name
Ranjit Manchanda
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Over 7000 UK women get ovarian cancer every year and over 4000 die from it. 7 in 10 women still present with advanced disease which has poor survival. The ‘Predicting-Risk of Ovarian-Malignancy Improved-Screening and Early-detection’ (PROMISE) ‘Feasibility-Study’ (FS) aims to evaluate the feasibility of undertaking a large study to (a)predict ovarian cancer risk; (b)group women according to their ovarian cancer risk: low/intermediate/high; (c)offer women different risk-based options to manage their ovarian cancer risk, such as screening, prevention and lifestyle based strategies. The PROMISE programme is an international research effort involving scientists/researchers from Manchester, University-College-London, Barts-Cancer-Institute(BCI) London, Cambridge, Cedars-Sinai(USA), Harvard(USA), and University-New-South-Wales(Sydney). New models to predict ovarian cancer risk, biomarkers and screening strategies have been developed within the PROMISE programme. It is funded by Cancer-Research-UK and The-Eve-Appeal.
Women over 18-years who haven’t had ovarian cancer are eligible to participate in this study run from BCI. Interested women will access a specially designed web-based ‘decision-aid’ and have access to a helpline to help them decide if they wish to participate in this study. Consenting participants will provide health-related information and a blood sample for genetic-testing for known ovarian cancer genes. Genetic-test results and information provided will be used in a specially developed mathematical model to predict ovarian cancer risk. Women found to be intermediate/high-risk will be offered options of screening (early-detection) and prevention through a specialist clinic at Bartshealth NHS trust. Early-detection involves a combination of blood tests for biomarkers and an ultrasound scan. Prevention can involve an operation to remove the tubes-&-ovaries (once family is complete). Participants will fill in questionnaires for a year regarding their satisfaction, acceptability, experience, and health/well-being from participating in this study. Researchers hope this approach of identifying more women at increased risk and offering options of early-detection and prevention can improve outcomes or prevent women from getting ovarian cancer itself.
REC name
London - Central Research Ethics Committee
REC reference
16/LO/2075
Date of REC Opinion
12 Jan 2017
REC opinion
Further Information Favourable Opinion