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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00897455

brca1 Mutation Carrier brca2 Mutation Carrier Breast Cancer

UNKNOWN

BRCA Mutations in Latinas

NCT01251900

Breast Neoplasms

COMPLETED

Susceptibility to Breast Cancer

NCT00004565

Breast Cancer Healthy

COMPLETED

Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Study

NCT00006425

Breast Cancer

COMPLETED

Genes and Other Risk Factors for Second Primary Breast Cancer in Women With Breast Cancer and Their Female Family Members and Friends

NCT00896818

Breast Cancer

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

BRCA1 Mutation Carrier BRCA2 Mutation Carrier Breast Carcinoma

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ancillary-Correlative (biomarker sampling and analysis)

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., 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 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.

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* No BRCA1/2 mutation-negative or mutation-unknown status
* Enrolled on clinical trial GOG-0199 AND meets the following criteria:

* Completed baseline questionnaire (BQ-199)
* Provided information on previous breast cancer history, including date of diagnosis
* Provided complete data from the DNA analysis on the genetic variants of interest
* Available DNA samples for analysis
* Hormone receptor status not specified
* Pre- or post-menopausal status

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No