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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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date July 13, 2017
Study Start Date May 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2015)
Identification of potential genetic modifiers of breast cancer risk [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
Identification of potential genetic modifiers of breast cancer risk
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers
Official Title Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers
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.
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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Not Provided
Condition
  • BRCA1 Mutation Carrier
  • BRCA2 Mutation Carrier
  • Breast Carcinoma
Intervention Other: Laboratory Biomarker Analysis
Correlative studies
Study Groups/Cohorts 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.
Intervention: Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: August 19, 2013)
0
Original Estimated Enrollment
 (submitted: May 9, 2009)
960
Study Completion Date Not Provided
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor Gynecologic Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Mark Greene Gynecologic Oncology Group
PRS Account Gynecologic Oncology Group
Verification Date July 2017