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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00899145 |
Purpose
RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers.
| Condition | Intervention |
|---|---|
|
brca1 Mutation Carrier brca2 Mutation Carrier Breast Cancer |
Genetic: DNA analysis Genetic: mutation analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Procedure: evaluation of cancer risk factors |
| Study Type: | Observational |
| Official Title: | Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers |
| Estimated Enrollment: | 960 |
| Study Start Date: | May 2008 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 and associated clinical information obtained from BRCA mutation-positive participants enrolled on GOG-0199 are studied. DNA samples are analyzed by mutation testing for variants (i.e., single nucleotide polymorphisms [SNPs]) in candidate genes of interest. Once genetic testing for a given set of variants has been completed, the coded laboratory data file is merged with selected demographic, clinical, and epidemiological data obtained from the GOG-0199 baseline questionnaire and submitted to the Consortium of Investigators of Modifiers of BRCA-Associated Breast Cancer (CIMBA) Central Database to analyze and publish the data. 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Women with or without a personal history of breast cancer prior to enrollment in Gynecologic Oncology Group (GOG)-0199
Known currently to be BRCA1/2 mutation carrier either by confirmed outside report or by research testing
Enrolled on clinical trial GOG-0199 AND meets the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
More Information
| Study ID Numbers: | CDR0000590275, GOG-0246 |
| Study First Received: | May 9, 2009 |
| Last Updated: | October 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00899145 History of Changes |
| Health Authority: | United States: Federal Government |
|
breast cancer breast cancer BRCA1 mutation carrier BRCA2 mutation carrier |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |