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Trial Title:
Studying Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers
NCT ID:
NCT00897455
Condition:
brca1 Mutation Carrier
brca2 Mutation Carrier
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
BRCA1 mutation carrier
BRCA2 mutation carrier
Study type:
Observational
Overall status:
Unknown status
Intervention:
Intervention type:
Genetic
Intervention name:
DNA analysis
Intervention type:
Genetic
Intervention name:
mutation analysis
Intervention type:
Genetic
Intervention name:
polymorphism analysis
Intervention type:
Other
Intervention name:
laboratory biomarker analysis
Intervention type:
Procedure
Intervention name:
evaluation of cancer risk factors
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.
Criteria for eligibility:
Criteria:
DISEASE CHARACTERISTICS:
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Address:
City:
Bethesda
Zip:
20892-1182
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone:
888-NCI-1937
Start date:
April 2008
Lead sponsor:
Agency:
Gynecologic Oncology Group
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00897455
