nited Kingdom Familial Ovarian Cancer Screening Study

Phase 1

Completed

• Conditions: Topic: National Cancer Research Network, Primary Care Research Network for England, Congenital Disorders; Subtopic: Gynaecological Cancer, Not Assigned, Congenital Disorders (all Subtopics); Disease: Ovary, Clinical Genetics, All Diseases; Ovarian cancer; Cancer

• Registration Number: ISRCTN32794457
• Lead Sponsor: niversity College London Hospitals NHS Foundation Trust (UK)

Brief Summary

2012 Results article in https://www.ncbi.nlm.nih.gov/pubmed/21999920 results 2012 Results article in https://www.ncbi.nlm.nih.gov/pubmed/22943881 results 2013 Results article in https://www.ncbi.nlm.nih.gov/pubmed/23213100 results 2013 Results article in https://www.ncbi.nlm.nih.gov/pubmed/23014947 results 2013 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24140203 results 2013 Results article in https://www.ncbi.nlm.nih.gov/pubmed/23801640 results 2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26315354 results 2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26629528 results 2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26261251 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28002811 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28240969 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-29
• Study Completion: 2020-12-31
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 5000

Inclusion Criteria

Inclusion in the study will be on the basis of a family history of cancer confirmed by histopathology report or death certification or a documented mutation of an OC causing gene. The UK FOCSS inclusion criteria have been devised to include all women who have a greater than or equal to 10% life time risk of ovarian cancer. This corresponds to a BRCA carrier probability of greater than or equal to 25% in the volunteer or greater than or equal to 50% in a FDR (first degree relative) of the volunteer including:
1. Families with ovarian or ovarian and breast cancer
2. Families with a known gene mutation
3. Families with colorectal cancer (HNPCC or Lynch syndrome)
4. Families with only breast cancer
5. Families with Ashkenazi Jewish ethnicity (additional criteria). Full details available from co-ordinating centre.
6. Female, aged between 35 and 75 years

Exclusion Criteria

1. Past history of bilateral salpingo-oophorectomy (N.B. Women who have undergone bilateral oophorectomy but who still have one or more Fallopian Tube in situ are eligible as they may be at increased risk of Fallopian Tube Cancer)
2. Less than 35 years of age
3. Women participating in other OC screening trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified