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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:
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

May 9, 2009
March 22, 2011
April 2008
December 2009   (final data collection date for primary outcome measure)
Identification of potential genetic modifiers of breast cancer risk [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00897455 on ClinicalTrials.gov Archive Site
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Studying Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers
Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers - CIMBA 5

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.

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.

Observational
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
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December 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
No
United States
 
NCT00897455
CDR0000598427, GOG-8008
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Gynecologic Oncology Group
National Cancer Institute (NCI)
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
National Cancer Institute (NCI)
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP