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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00899145

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
BRCA1 Mutation Carrier BRCA2 Mutation Carrier Breast Carcinoma	Other: Laboratory Biomarker Analysis

Detailed Description

OBJECTIVE:

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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Official Title:

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

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Laboratory Biomarker Analysis Correlative studies

Arm

Intervention/Treatment

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.

Other: Laboratory Biomarker Analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

Identification of potential genetic modifiers of breast cancer risk [Up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynecologic Oncology Group	Philadelphia	Pennsylvania	United States	19103

Sponsors and Collaborators

Gynecologic Oncology Group
National Cancer Institute (NCI)

Investigators

Principal Investigator: Mark Greene, Gynecologic Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gynecologic Oncology Group

ClinicalTrials.gov Identifier:

NCT00899145

Other Study ID Numbers:

GOG-0246
NCI-2009-00608
CDR0000590275
GOG-0246
GOG-0246
U10CA101165

First Posted:

May 12, 2009

Last Update Posted:

Jul 13, 2017

Last Verified:

Jul 1, 2017

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jul 13, 2017