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

Primary Purpose

brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer

Status

Unknown status

Phase

Locations

United States

Study Type

Observational

Intervention

DNA analysis

mutation analysis

polymorphism analysis

laboratory biomarker analysis

evaluation of cancer risk factors

About this trial

This is an observational trial for brca1 Mutation Carrier focused on measuring breast cancer, BRCA1 mutation carrier, BRCA2 mutation carrier

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeRecruiting

Outcomes

Primary Outcome Measures

Identification of potential genetic modifiers of breast cancer risk

Secondary Outcome Measures

Full Information

NCT ID

NCT00897455

First Posted

May 9, 2009

Last Updated

March 22, 2011

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00897455

Brief Title

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

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

April 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer

Keywords

breast cancer, BRCA1 mutation carrier, BRCA2 mutation carrier

7. Study Design

Enrollment

10000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Genetic

Intervention Name(s)

DNA analysis

Intervention Type

Genetic

Intervention Name(s)

mutation analysis

Intervention Type

Genetic

Intervention Name(s)

polymorphism analysis

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Type

Procedure

Intervention Name(s)

evaluation of cancer risk factors

Primary Outcome Measure Information:

Title

Identification of potential genetic modifiers of breast cancer risk

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark H. Greene, MD

Organizational Affiliation

Clinical Genetics Branch

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Michael Birrer, MD, PhD

Organizational Affiliation

NCI - Cell and Cancer Biology Branch

First Name & Middle Initial & Last Name & Degree

Phuong Mai, MD

Organizational Affiliation

Clinical Genetics Branch

Facility Information:

Facility Name

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892-1182

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trials Office - Warren Grant Magnusen Clinical Center

Phone

888-NCI-1937

12. IPD Sharing Statement

Learn more about this trial

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

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