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

Breast Cancer Clinical Trial

Official title:

Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers - CIMBA 5

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00897455
• Other study ID #: CDR0000598427
• Secondary ID: GOG-8008
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: March 22, 2011
• Start date: April 2008

Study information

• Verified date: March 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• brca1 Mutation Carrier
• brca2 Mutation Carrier
• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• DNA analysis

• mutation analysis

• polymorphism analysis

Other:
• laboratory biomarker analysis

Procedure:
• evaluation of cancer risk factors

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of potential genetic modifiers of breast cancer risk			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database