United Kingdom Familial Ovarian Cancer Screening Study
| ISRCTN | ISRCTN32794457 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32794457 |
| ClinicalTrials.gov (NCT) | NCT00033488 |
| Protocol serial number | 1069; Current Version 10.0 |
| Sponsor | University College London Hospitals NHS Foundation Trust (UK) |
| Funders | Cancer Research UK (CRUK) (UK) (ref: C1005/A6383), National Institute for Health Research (NIHR) (UK), The Eve Appeal (UK) |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 31/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Usha Menon
Scientific
Scientific
MRC Clinical Trials Unit at UCL
Institute of Clinical Trials & Methodology
2nd Floor, 90 High Holborn
London
WC1V 6LJ
United Kingdom
 ORCID ID |
0000-0003-3708-1732 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised interventional screening trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A non-randomised interventional screening trial for women at high risk of ovarian/fallopian tube cancer |
| Study acronym | UK FOCSS |
| Study objectives | 5,000 women at high risk of ovarian/fallopian tube cancer due to a strong family history or known mutation in predisposing genes are being screened annually with transvaginal ultrasound and every four months with the serum tumour marker CA125. CA125 levels are processed using a Risk of Ovarian Cancer Algorithm (ROCA), which stratifies women according to their age, menopausal status and pattern of CA125 over time. Women with intermediate ROCA results have a repeat ultrasound. Women with suspicious scans or highly elevated ROCA results are referred to a gynaecologist for consideration of surgical investigation. Screening is coordinated from University College London via an online database accessible by collaborating national centres. All CA125 tests are processed centrally at UCL. The aims of the research are to develop an optimised screening procedure for ovarian cancer in high-risk women, to determine the physical morbidity, resource implications and feasibility of screening this high-risk population and to establish a serum bank for future assessment of novel tumour markers. |
| Ethics approval(s) | Cambridgeshire 4 REC, 11/12/2001, ref: 97/5/007 |
| Health condition(s) or problem(s) studied | 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 |
| Intervention | Intervention comprised of two screening tests: 1. 4-monthly CA125 blood tests 2. An annual transvaginal ultrasound scan Study entry: registration only Updated 23/10/2018: Phase 1: Annual screening Phase 2: Four-monthly screening |
| Intervention type | Other |
| Primary outcome measure(s) |
Diagnosis/stage/grade of primary invasive epithelial ovarian/fallopian tube cancer, measured during and one year after the end of active screening (June 2012) |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 5000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/06/2002 |
| Date of final enrolment | 30/04/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UCL Faculty of Biomedical Sciences
London
W1T 7JA
United Kingdom
W1T 7JA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No | |
| Results article | results | 01/12/2012 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No | |
| Results article | results | 01/03/2013 | Yes | No | |
| Results article | results | 01/11/2013 | Yes | No | |
| Results article | results | 01/11/2013 | Yes | No | |
| Results article | results | 27/08/2015 | Yes | No | |
| Results article | results | 09/09/2015 | Yes | No | |
| Results article | results | 10/09/2015 | Yes | No | |
| Results article | results | 17/01/2017 | Yes | No | |
| Results article | results | 01/05/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 31/03/2022 | No | Yes | ||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/03/2022: Plain English results added.
23/10/2018: The following changes were made to the trial record:
1. The contact details and interventions were updated.
2. The overall trial end date was changed from 30/04/2018 to 31/12/2020.
3. Publication references added.
09/05/2014: The overall trial end date was changed from 31/03/2010 to 30/04/2018.
