Screening Study for Ovarian Cancer in Women Who are at High Genetic Risk for Developing Ovarian Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.(Closed to Accrual as of 3/31/2010)

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Alternate Title

Screening Women at High Genetic Risk for Ovarian Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information. (Closed to Accrual as of 3/31/2010)

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedScreeningClosed35 and overOtherUKFOCSS
CRCA-FOCS, EU-20044, NCT00033488

Objectives

  1. 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.
  2. Determine the physical morbidity and the resource implications associated with ovarian cancer screening in these women.
  3. Assess the feasibility of screening this high-risk population in terms of compliance rates.

Entry Criteria

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

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

Patient Characteristics:

    Age:

  • 35 and over

    Performance status:

  • Not specified

    Life expectancy:

  • Not specified

    Hematopoietic:

  • Not specified

    Hepatic:

  • Not specified

    Renal:

  • Not specified

Expected Enrollment

5000

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

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

Trial Contact Information

Trial Lead Organizations

University College Hospital

James Mackay, MD, MA, FRCP, FRCPE, Protocol chair
Ph: 44-20-7679-8099
Email: j.mackay@ich.ucl.ac.uk

Registry Information

Official TitleThe UK Familial Ovarian Cancer Screening Study
Trial Start Date2000-09-01
Registered in ClinicalTrials.govNCT00033488
Date Submitted to PDQ2002-02-12
Information Last Verified2007-06-11

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.