Ovarian cancer Cancer Malignant neoplasm of ovary
Conditions
Interventions
This is a pilot implementation of the ROCA Test into the NHS in women with BRCA1 or BRCA2 who are at high risk of developing ovarian cancer.
Participants will be under surveillance using the ROCA Tes
premenopausal women will need to answer them at each routine sample.
The blood sample is then analysed for the blood chemical CA125, with the result being sent back to the project manager via secure
Sponsors
University College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women who have tested postive for a pathogenic BRCA1 or BRCA2 mutation 2. Women aged 35 years or over 3. Women who still have at least one ovary or fallopian tube in situ 4. Women who are able and willing to travel to one of the named referral centres
Exclusion criteria
Exclusion criteria: 1. Women who have tested negative for pathogenic BRCA1 or BRCA2 gene mutation 2. Women who have not been tested for a pathogenic BRCA1 or BRCA2 gene mutation 3. Women who are less than 35 years of age 4. Women who are pregnant are not eligible for the ROCA® Test until 6 weeks after the end of their pregnancy. Neither CA125 nor ultrasound scanning can be used reliably to screen for OC during pregnancy 5. Women with a past history of bilateral salpingo-oophorectomy (Note: Women who still have one or more fallopian tube or ovary in situ are still eligible as they remain at increased risk of ovarian/tubal cancer) 6. Women previously treated for an ovarian malignancy 7. Women who are under investigation for suspected OC 8. Women currently being treated or within 6 weeks of treatment for any other malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of ovarian cancers (OC) detected through the ROCA Test and the stage and grade of these cancers, measured using surgery and histopathology reports, reviewed by a pathologist throughout the surveillance and for 6 months of follow up. OC specifically refers to ‘invasive epithelial ovarian cancer’ and does not include ‘borderline ovarian tumour’ | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of women presenting to A&E with ovarian cancer symptoms, determined by the route of diagnosis (picked up by the surveillance or through emergency admission with symptoms). This will be assessed through all clinic letters and surgery and histopathology results in women diagnosed with OC throughout the project and for 6 months of follow up 2. The cost of surveillance in terms of treatment and surgery measured using a Markov model at 1 year 3. Participants experience of participating, measured using questionnaire data at baseline and at withdrawal (for those that withdraw during the trial) or at end of surveillance | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed