ROCkeTS
Research type
Research Study
Full title
Refining Ovarian Cancer Test Accuracy Scores: A test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer.
IRAS ID
168143
Contact name
Sudha Sundar
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
3 years, 6 months, 5 days
Research summary
Our research project will identify and confirm tests that can help hospital doctors and GP’s make a better diagnosis of ovarian cancer.
NICE has issued guidelines to GP’s, to test women if they have certain symptoms of bloating/tummy discomfort with a blood test CA125 and then a pelvic ultrasound if the CA125 test result is abnormal. However published literature shows GPs refer patients if they have symptoms or if either test is abnormal. In fact the blood test CA125 can be raised in lots of other innocent conditions e.g. during menstrual periods. Also in younger women, non-cancerous cysts on the ovary are very common. Conversely CA125 is only raised in half the women with early ovarian cancer. This means that many women are referred who actually have a very low risk of cancer, and others are not referred until their cancer has reached a more advanced stage.
By identifying better tests for ovarian cancer, we may be able to diagnose more women with ovarian cancer early but also reduce unnecessary tests, hospital visits and distress in women who don’t have cancer. We also know that women with ovarian cancer who undergo thorough surgery by a gynaecological cancer specialist have the best outcomes, so improved testing in hospital after referral may also help to identify the patients who will need this.
Rockets study is a part of a large complex project that will first look at all the published papers on new blood tests, scan scoring and symptom scores. We will then use that information to test existing stored blood samples and data from previous large studies conducted by our collaborators, to fine-tune tests and create new scoring systems (risk prediction models) which can be used to diagnose patients by GPs and after referral in hospital. We will then compare our new risk prediction model against the current prediction score (RMI) in a study of 2450 newly presenting patients with suspected ovarian cancer. This study will assess symptoms, scans and blood test results. Finally we will use all of this information to set out best pathways for GP’s and hospital specialists to follow in women with suspected ovarian cancer. This ethics application is for the prospective study only.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
14/WM/1241
Date of REC Opinion
5 Jan 2015
REC opinion
Further Information Favourable Opinion