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
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|
|Ovarian Cancer||Other: cytology specimen collection procedure Procedure: annual screening Procedure: comparison of screening methods||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5000 participants|
|Official Title:||The UK Familial Ovarian Cancer Screening Study|
|Study Start Date :||September 2000|
|Actual Study Completion Date :||March 2010|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033488
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Institute of Child Health|
|London, England, United Kingdom, WC1N 1EH|
|Study Chair:||James Mackay, MD, MA, FRCP, FRCPE||Institute of Child Health|