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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00899145
First received: May 9, 2009
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers.


Condition Intervention
brca1 Mutation Carrier
brca2 Mutation Carrier
Breast Cancer
Genetic: DNA analysis
Genetic: mutation analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Procedure: evaluation of cancer risk factors

Study Type: Observational
Official Title: Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Identification of potential genetic modifiers of breast cancer risk [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Pre- or post-menopausal status

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899145

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Philip J. DiSaia, MD Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00899145     History of Changes
Other Study ID Numbers: GOG-0246, CDR0000590275, NCI-2009-00608
Study First Received: May 9, 2009
Last Updated: August 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
breast cancer
BRCA1 mutation carrier
BRCA2 mutation carrier

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 11, 2014