Screening Women at High Genetic Risk for Ovarian Cancer

University College London Hospitals5,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

SCREENING

Enrollment

5,000

Conditions

Ovarian Cancer

Interventions

cytology specimen collection procedureOTHER

annual screeningPROCEDURE

comparison of screening methodsPROCEDURE

Eligibility

Sex: FEMALEMin age: 35 Years

Medical Language ↔ Plain English

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

Locations (2)

Saint Bartholomew's Hospital

London, England, United Kingdom

Institute of Child Health

London, England, United Kingdom

Data from ClinicalTrials.gov

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