Screening Women at High Genetic Risk for Ovarian Cancer
NCT ID: NCT00033488
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5000 participants
INTERVENTIONAL
2000-09-30
2010-03-31
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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SCREENING
Interventions
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cytology specimen collection procedure
annual screening
comparison of screening methods
Eligibility Criteria
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Inclusion Criteria
* 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
35 Years
FEMALE
No
Sponsors
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University College London Hospitals
OTHER
Principal Investigators
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James Mackay, MD, MA, FRCP, FRCPE
Role: STUDY_CHAIR
Institute of Child Health
Locations
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Saint Bartholomew's Hospital
London, England, United Kingdom
Institute of Child Health
London, England, United Kingdom
Countries
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Other Identifiers
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UKFOCSS
Identifier Type: -
Identifier Source: secondary_id
CRCA-FOCS
Identifier Type: -
Identifier Source: secondary_id
EU-20044
Identifier Type: -
Identifier Source: secondary_id
CDR0000069292
Identifier Type: -
Identifier Source: org_study_id