- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00033488
Screening Women at High Genetic Risk for Ovarian Cancer
The UK Familial Ovarian Cancer Screening Study
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
England
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London, England, United Kingdom, EC1A 7BE
- Saint Bartholomew's Hospital
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London, England, United Kingdom, WC1N 1EH
- Institute of Child Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
Collaborators and Investigators
Investigators
- Study Chair: James Mackay, MD, MA, FRCP, FRCPE, Institute of Child Health
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- CDR0000069292
- UKFOCSS
- CRCA-FOCS
- EU-20044
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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