Condition category
Cancer
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
23/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Usha Menon

ORCID ID

http://orcid.org/0000-0003-3708-1732

Contact details

MRC Clinical Trials Unit at UCL
Institute of Clinical Trials & Methodology
2nd Floor
90 High Holborn
London
WC1V 6LJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00033488

Protocol/serial number

1069; Current Version 10.0

Study information

Scientific title

A non-randomised interventional screening trial for women at high risk of ovarian/fallopian tube cancer

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

Cambridgeshire 4 REC, 11/12/2001, ref: 97/5/007

Study design

Non-randomised interventional screening trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Can be found at http://www.instituteforwomenshealth.ucl.ac.uk/academic_research/gynaecologicalcancer/gcrc/ukfocss/pis.pdf

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

Phase

Phase I

Drug names

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 trial start date

05/06/2002

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 5000; UK Sample Size: 5000

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

United Kingdom

Trial participating centre

UCL Faculty of Biomedical Sciences
London
W1T 7JA
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

Joint UCLH/UCL Biomedical Research Unit
1st Floor Maple House
149 Tottenham Court Road
London
W1P 9LL
United Kingdom

Sponsor type

Government

Website

http://www.ucl.ac.uk/joint-rd-unit/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C1005/A6383)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

The Eve Appeal (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Core trial publications:
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23213100
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28240969

Secondary studies:
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/24140203
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26261251
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26629528
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26315354
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28002811

UK FOCSS Psychosocial Study (PsyFOCS):
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/21999920
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22943881
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23014947
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23801640

Publication citations

  1. Results

    Rosenthal, A. N., Fraser, L. S. M., Philpott, S., Manchanda, R., Burnell, M., Badman, P., . . . Jacobs, I. J., Evidence of stage-shift in women diagnosed with ovarian cancer during Phase II of the United Kingdom Familial Ovarian Cancer Screening Study, J Clin Oncol, 2017, doi: 10.1200/JCO.2016.69.9330.

  2. Results

    Rosenthal, A. N., Fraser, L., Manchanda, R., Badman, P., Philpott, S., Mozersky, J., . . . Jacobs, I. J. , Results of annual screening in phase I of the United Kingdom familial ovarian cancer screening study highlight the need for strict adherence to screening schedule, J Clin Oncol, 2013, 31 , 1, 49-57, doi: 10.1200/JCO.2011.39.7638.

Additional files

Editorial Notes

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.