United Kingdom Familial Ovarian Cancer Screening Study
| ISRCTN | ISRCTN32794457 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32794457 |
| ClinicalTrials.gov number | NCT00033488 |
| Secondary identifying numbers | 1069; Current Version 10.0 |
- 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
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
| Study design | Non-randomised interventional screening trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Can be found at http://www.instituteforwomenshealth.ucl.ac.uk/academic_research/gynaecologicalcancer/gcrc/ukfocss/pis.pdf |
| Scientific title | A non-randomised interventional screening trial for women at high risk of ovarian/fallopian tube cancer |
| Study acronym | UK FOCSS |
| Study hypothesis | 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 |
| Condition | 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 | Diagnosis/stage/grade of primary invasive epithelial ovarian/fallopian tube cancer, measured during and one year after the end of active screening (June 2012) |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 05/06/2002 |
| Overall study end date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 5000; UK Sample Size: 5000 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 05/06/2002 |
| Recruitment end date | 30/04/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UCL Faculty of Biomedical Sciences
London
W1T 7JA
United Kingdom
W1T 7JA
United Kingdom
Sponsor information
University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Joint UCLH/UCL Biomedical Research Unit
1st Floor Maple House
149 Tottenham Court Road
London
W1P 9LL
England
United Kingdom
| Website | http://www.ucl.ac.uk/joint-rd-unit/ |
|---|---|
"ROR" |
https://ror.org/042fqyp44 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C1005/A6383)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
National Institute for Health Research (NIHR) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
The Eve Appeal (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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 | |
| Plain English results | 31/03/2022 | 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.
