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Brief Title: Screening Women at High Genetic Risk for Ovarian Cancer
Official Title: The UK Familial Ovarian Cancer Screening Study
Study ID: NCT00033488
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.
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.
Minimum Age: 35 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Saint Bartholomew's Hospital, London, England, United Kingdom
Institute of Child Health, London, England, United Kingdom
Name: James Mackay, MD, MA, FRCP, FRCPE
Affiliation: Institute of Child Health
Role: STUDY_CHAIR