ALDO
Research type
Research Study
Full title
Avoiding Late Diagnosis of Ovarian Cancer
IRAS ID
245363
Contact name
Adam Rosenthal
Contact email
Sponsor organisation
UCL
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Research Summary
Women with BRCA1 or BRCA2 mutation are at a high risk of developing Ovarian Cancer (OC). The only way to prevent OC is surgery to remove their ovaries and fallopian tubes. Having surgery is a major decision however as it causes infertility and early menopause, so many women choose to delay surgery until their families are complete or they have reached the natural menopause, leaving them at risk of developing OC in the meantime. Some women decline surgery even after the menopause. OCs diagnosed with symptoms are usually diagnosed at a late stage, which can result in more complex surgery, longer hospital stays and poorer survival. The ALDO project will offer a surveillance option to women declining surgery, using the ROCA blood Test which has been shown to detect OC at earlier stages compared to women with symptoms. The ROCA Test calculates the probability of someone having OC based on age, menopause status and changes in CA125 blood levels. Women taking part will have a routine blood sample for CA125 taken 4 monthly for one year. The CA125 is run through the ROCA Test which gives a risk score for how likely it is they currently have OC. Women with a normal score will continue with 4-monthly surveillance tests; women with an elevated score will have the test repeated sooner and may also require an ultrasound scan of their pelvis and referral to a ‘rapid-access’ gynaecology clinic. The primary objective is to provide evidence to support widespread implementation of the ROCA Test within the NHS, by showing it can detect earlier stage cancers, is cost effective and is a positive experience for women at high risk of OC. This will be done by working with health economists, the National Institute for Health and Care Excellence (NICE) and NHS commissioners.
Summary of Results
Women with inherited BRCA1/2 gene alterations are at high risk of ovarian cancer, so usually opt for surgery to remove their ovaries and tubes. Many women delay surgery to complete families or avoid premature menopause. This study confirmed previous research showing that a 4-monthly blood test can detect ovarian cancer at earlier stages, resulting in less complex surgery, a high chance of removing all visible cancer, and cost-savings to the UK health service. Surveillance should be viewed strictly as short-term, as it cannot prevent cancer, and delaying surgery could result in women being diagnosed with an incurable ovarian cancer.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
18/WM/0144
Date of REC Opinion
13 Jun 2018
REC opinion
Further Information Favourable Opinion