Screening Women at High Genetic Risk for Ovarian Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The UK Familial Ovarian Cancer Screening Study

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Other: cytology specimen collection procedure
* Procedure: annual screening
* Procedure: comparison of screening methods


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cytology specimen collection procedure|nan|
|Procedure: annual screening|nan|
|Procedure: comparison of screening methods|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian epithelial cancer