The UK Familial Ovarian Cancer Screening Study
35 Years
N/A
Female
Ovarian Cancer
Trial Information
The UK Familial Ovarian Cancer Screening Study
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Screening
Principal Investigator
James Mackay, MD, MA, FRCP, FRCPE
Investigator Role:
Study Chair
Investigator Affiliation:
Institute of Child Health
Authority:
United States: Federal Government
Study ID:
CDR0000069292
NCT ID:
NCT00033488
Start Date:
September 2000
Completion Date:
Related Keywords:
- Ovarian Cancer
- ovarian epithelial cancer
- Ovarian Neoplasms
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