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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00899145
Recruitment Status : Withdrawn
First Posted : May 12, 2009
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

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
BRCA1 Mutation Carrier BRCA2 Mutation Carrier Breast Carcinoma Other: Laboratory Biomarker Analysis

Detailed Description:

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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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 2008
Actual Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort 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




Primary Outcome Measures :
  1. Identification of potential genetic modifiers of breast cancer risk [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899145


Locations
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United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mark Greene Gynecologic Oncology Group
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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00899145    
Other Study ID Numbers: GOG-0246
NCI-2009-00608 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000590275
GOG-0246 ( Other Identifier: Gynecologic Oncology Group )
GOG-0246 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases