Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Screening Women at High Genetic Risk for Ovarian Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information. (Closed to Accrual as of 3/31/2010)

Basic Trial Information

Objectives

1. 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.
2. Determine the physical morbidity and the resource implications associated with ovarian cancer screening in these women.
3. Assess the feasibility of screening this high-risk population in terms of compliance rates.

Entry 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 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

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

Patient Characteristics:

Age:

• 35 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Expected Enrollment

A total of 5,000 patients will be accrued for this study.

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

Trial Contact Information

Trial Lead Organizations

University College Hospital

James Mackay, MD, MA, FRCP, FRCPE, Protocol chair		Ph: 44-20-7679-8099 Email: j.mackay@ich.ucl.ac.uk

Registry Information
Official Title		The UK Familial Ovarian Cancer Screening Study
Trial Start Date		2000-09-01
Registered in ClinicalTrials.gov		NCT00033488
Date Submitted to PDQ		2002-02-12
Information Last Verified		2007-06-11

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