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Screening Women at High Genetic Risk for Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00033488
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

April 9, 2002
January 27, 2003
December 18, 2013
September 2000
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Complete list of historical versions of study NCT00033488 on ClinicalTrials.gov Archive Site
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Screening Women at High Genetic Risk for Ovarian Cancer
The UK Familial Ovarian Cancer Screening Study

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.

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.

Interventional
Not Applicable
Primary Purpose: Screening
Ovarian Cancer
  • Other: cytology specimen collection procedure
  • Procedure: annual screening
  • Procedure: comparison of screening methods
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5000
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March 2010
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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
Sexes Eligible for Study: Female
35 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00033488
CDR0000069292
UKFOCSS
CRCA-FOCS
EU-20044
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University College London Hospitals
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Study Chair: James Mackay, MD, MA, FRCP, FRCPE Institute of Child Health
National Cancer Institute (NCI)
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP