Breast Carcinoma Clinical Trial
Official title:
Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers
This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers. Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors identify biomarkers related to cancer.
OBJECTIVE:
I. To identify potential genetic modifiers of breast cancer risk in women who are carriers of
the breast cancer susceptibility genes, BRCA1/2, by collecting data and genetic information
from GOG-0199 and contributing it to the Consortium of Investigators of Modifiers of
BRCA-Associated Breast Cancer (CIMBA), an international consortium of clinical cancer
genetics investigators.
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.
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