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

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

March 22, 2011

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00897455 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

brca1 Mutation Carrier
brca2 Mutation Carrier
Breast Cancer

Intervention ^ICMJE

Genetic: DNA analysis
Genetic: mutation analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Procedure: evaluation of cancer risk factors

Study Group/Cohort (s)

Not Provided

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 ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

10000

Completion Date

Not Provided

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00897455

Other Study ID Numbers ^ICMJE

CDR0000598427, GOG-8008

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Gynecologic Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

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

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2011

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

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