Clincosm LogoSign in Get a demo

Screening Women at High Genetic Risk for Ovarian Cancer

Sponsor
University College London Hospitals (Other)
Overall Status
Completed
CT.gov ID
NCT00033488
Collaborator
(none)
5,000
Enrollment
2
Locations
113.9
Duration (Months)
2500
Patients Per Site
21.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer.

PURPOSE: Screening trial to determine the best procedure to detect ovarian cancer in women who have a high genetic risk for developing ovarian cancer.

Condition or Disease Intervention/Treatment Phase
  • Other: cytology specimen collection procedure
  • Procedure: annual screening
  • Procedure: comparison of screening methods
 N/A

Detailed Description

OBJECTIVES:

  • Determine an optimal screening procedure for ovarian cancer, in terms of the most appropriate screening test, criteria for interpretation of results, and screening intervals, in women at high genetic risk for developing ovarian cancer.

  • Determine the physical morbidity and the resource implications associated with ovarian cancer screening in these women.

  • Assess the feasibility of screening this high-risk population in terms of compliance rates.

OUTLINE: Patients undergo transvaginal ultrasonography of the ovaries (scheduled for the early follicular phase, day 3-6 of the menstrual cycle) and CA 125 measurement annually. Blood samples are collected every 4 months for analysis of CA 125 levels and novel markers.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5000 participants
Primary Purpose:
Screening
Official Title:
The UK Familial Ovarian Cancer Screening Study
Study Start Date :
Sep 1, 2000
Actual Study Completion Date :
Mar 1, 2010

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • First-degree relative (mother, sister, or daughter) of an affected member of a high-risk family defined as one of the following:

    • Family containing 2 or more individuals with ovarian cancer who are connected by first-degree relationships

    • Family containing 1 individual with ovarian cancer and 1 individual with breast cancer and under 50 years of age at the time of diagnosis who are connected by first-degree relationships

    • Family containing 1 individual with ovarian cancer and 2 individuals with breast cancer and under 60 years of age at the time of diagnosis who are connected by first-degree relationships

    • Family containing an affected individual with a mutation of one of the known ovarian cancer predisposing genes

    • Family containing 3 individuals with colorectal cancer with at least 1 individual under 50 years of age at time of diagnosis and 1 individual with ovarian cancer who are connected by first-degree relationships

    • Families where affected relatives are related by second-degree relationships through an unaffected intervening male relative who has an affected daughter are allowed

    PATIENT CHARACTERISTICS:
    Age:
    • 35 and over
    Performance status:
    • Not specified
    Life expectancy:
    • Not specified
    Hematopoietic:
    • Not specified
    Hepatic:
    • Not specified
    Renal:
    • Not specified
    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:
    • Not specified
    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • Not specified
    Surgery:
    • No prior bilateral oophorectomy
    Other:
    • No concurrent participation in other ovarian cancer screening trials

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint Bartholomew's Hospital London England United Kingdom EC1A 7BE
    2 Institute of Child Health London England United Kingdom WC1N 1EH

    Sponsors and Collaborators

    • University College London Hospitals

    Investigators

    • Study Chair: James Mackay, MD, MA, FRCP, FRCPE, Institute of Child Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00033488
    Other Study ID Numbers:
    • CDR0000069292
    • UKFOCSS
    • CRCA-FOCS
    • EU-20044
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Dec 18, 2013
    Last Verified:
    Jun 1, 2007
    Keywords provided by , ,
    ovarian epithelial cancer
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Dec 18, 2013