Studying Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers
|ClinicalTrials.gov Identifier: NCT00897455|
Recruitment Status : Unknown
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 12, 2009
Last Update Posted : March 23, 2011
RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors learn more about cancer and identify biomarkers related to cancer.
PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers.
|Condition or disease||Intervention/treatment|
|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|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers - CIMBA 5|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||December 2009|
- Identification of potential genetic modifiers of breast cancer risk
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897455
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Recruiting|
|Bethesda, Maryland, United States, 20892-1182|
|Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937|
|Study Chair:||Mark H. Greene, MD||Clinical Genetics Branch|
|OverallOfficial:||Michael Birrer, MD, PhD||NCI - Cell and Cancer Biology Branch|
|OverallOfficial:||Phuong Mai, MD||Clinical Genetics Branch|