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	Treatment or Intervention
ovarian epithelial cancer	Procedure: annual screening  Procedure: comparison of screening methods  Procedure: cytologic sampling  Procedure: screening intervention

Further Study Details: 

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.

PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 3 years.

Ages Eligible for Study:  35 Years and above,  Genders Eligible for Study:  Both

Criteria

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 first-degree relatives
• 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 first-degree relative
• 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 sister 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

United Kingdom, England
      Institute of Child Health, London,  England,  WC1N 1EH,  United Kingdom; Recruiting
      Saint Bartholomew's Hospital, London,  England,  EC1A 7BE,  United Kingdom; Recruiting

Study chairs or principal investigators

James Mackay, MD,  Study Chair,  Institute of Child Health   

Study ID Numbers:  CDR0000069292; UKFOCSS; CRCA-FOCS; EU-20044; NCT00033488
Record last reviewed:  April 2002
Last Updated:  December 3, 2004
Record first received:  April 9, 2002
ClinicalTrials.gov Identifier:  NCT00033488
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08