Studying Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers
NCT ID: NCT00897455
Last Updated: 2011-03-23
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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UNKNOWN
10000 participants
OBSERVATIONAL
2008-04-30
Brief Summary
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PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers.
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Detailed Description
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* To identify potential genetic modifiers of breast cancer risk by contributing data and genetic information obtained from women who are BRCA1/BRCA2 mutation carriers enrolled in clinical trial GOG-0199 to an international consortium of clinical cancer genetics investigators (CIMBA).
OUTLINE: This is a multicenter study. Patients are stratified by study, country of residence, ethnicity, and birth cohort. Joint analyses of BRCA1 and BRCA2 mutation carriers are further stratified by mutation.
Previously collected DNA samples are analyzed for genetic variants in selected candidate genes (rs16942 in BRCA1, rs2237060 in RAD50, "SNP3", and rs2241193 in IGFBP5). The single nucleotide polymorphism (SNP) data from this study and selected demographic, clinical, and epidemiological data obtained from the baseline questionnaire administered in the GOG-0199 study are submitted to the Consortium of Investigators of Modifiers of BRCA-Associated Cancer (CIMBA) Central Database. The epidemiological and SNP data contributed to the Central Database are then distributed to the investigators responsible for analysis of a particular SNP or set of SNPs from a candidate gene or genetic pathway.
Conditions
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Interventions
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DNA analysis
mutation analysis
polymorphism analysis
laboratory biomarker analysis
evaluation of cancer risk factors
Eligibility Criteria
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Inclusion Criteria
* Known positive BRCA1/BRCA2 mutation carrier
* With or without a personal history of breast cancer prior to enrollment in clinical trial GOG-0199
* Currently enrolled in clinical trial GOG-0199 AND meets the following criteria:
* Completed baseline questionnaire (BQ-199)
* Provided information on prior breast cancer history, including date of diagnosis
* Provided complete data from the DNA analysis on the genetic variants of interest
* Signed an approved informed consent and authorization permitting release of personal health information
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
80 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Mark H. Greene, MD
Role: STUDY_CHAIR
Clinical Genetics Branch
Michael Birrer, MD, PhD
Role:
NCI - Cell and Cancer Biology Branch
Phuong Mai, MD
Role:
Clinical Genetics Branch
Locations
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Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States
Countries
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Facility Contacts
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Clinical Trials Office - Warren Grant Magnusen Clinical Center
Role: primary
Other Identifiers
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GOG-8008
Identifier Type: -
Identifier Source: secondary_id
CDR0000598427
Identifier Type: -
Identifier Source: org_study_id
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