NCT00897455

Studying Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers

Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers - CIMBA 5

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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

• brca1 Mutation Carrier
• brca2 Mutation Carrier
• Breast Cancer

Interventions

Type	Name	Description
GENETIC	DNA analysis
GENETIC	mutation analysis
GENETIC	polymorphism analysis
OTHER	laboratory biomarker analysis
PROCEDURE	evaluation of cancer risk factors

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-12-01
• First posted: 2009-05-12
• Last updated: 2011-03-23

Locations

1 site across 1 country: United States