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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897455
First received: May 9, 2009
Last updated: March 22, 2011
Last verified: March 2011
History of Changes
  Purpose

RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors learn more about cancer and 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 - CIMBA 5

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 10000
Study Start Date: April 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To identify potential genetic modifiers of breast cancer risk by contributing data and genetic information obtained from women who are BRCA1/BRCA2 mutation carriers enrolled in clinical trial GOG-0199 to an international consortium of clinical cancer genetics investigators (CIMBA).

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 are analyzed for genetic variants in selected candidate genes (rs16942 in BRCA1, rs2237060 in RAD50, "SNP3", and rs2241193 in IGFBP5). The single nucleotide polymorphism (SNP) data from this study and selected demographic, clinical, and epidemiological data obtained from the baseline questionnaire administered in the GOG-0199 study are submitted to the Consortium of Investigators of Modifiers of BRCA-Associated Cancer (CIMBA) Central Database. 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:

  • Known positive BRCA1/BRCA2 mutation carrier
  • With or without a personal history of breast cancer prior to enrollment in clinical trial GOG-0199

  • Currently enrolled in clinical trial GOG-0199 AND meets the following criteria:

    • Completed baseline questionnaire (BQ-199)
    • Provided information on prior breast cancer history, including date of diagnosis
    • Provided complete data from the DNA analysis on the genetic variants of interest
    • Signed an approved informed consent and authorization permitting release of personal health information
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897455

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Mark H. Greene, MD Clinical Genetics Branch
Investigator: Michael Birrer, MD, PhD NCI - Cell and Cancer Biology Branch
Investigator: Phuong Mai, MD Clinical Genetics Branch
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00897455     History of Changes
Other Study ID Numbers: CDR0000598427, GOG-8008
Study First Received: May 9, 2009
Last Updated: March 22, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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 May 21, 2013