Recruiting

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

Sponsor:

Gynecologic Oncology Group

Code:

NCT00897455

Conditions

brca1 Mutation Carrier

brca2 Mutation Carrier

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DNA analysis

mutation analysis

polymorphism analysis

laboratory biomarker analysis

evaluation of cancer risk factors

Study Details

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.

Conditions

brca1 Mutation Carrier

brca2 Mutation Carrier

Breast Cancer

Study ID

NCT00897455

Start date

Apr, 2008

Status verified date

Mar, 2011

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Interventions

DNA analysis

mutation analysis

polymorphism analysis

laboratory biomarker analysis

evaluation of cancer risk factors

Primary outcome measure

Identification of potential genetic modifiers of breast cancer risk [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Recruiting

Bethesda, Maryland, United States, 20892-1182

Contacts

Clinical Trials Office - Warren Grant Magnusen Clinical Center

888-NCI-1937

More Information

Sponsor

Gynecologic Oncology Group

Last update posted

Mar 23, 2011

Last verified

Mar, 2011

Keywords

breast cancer
BRCA1 mutation carrier
BRCA2 mutation carrier

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gynecologic Oncology Group on 2011-03-23.