NCT00897455

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

March 23, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

May 9, 2009

Last Update Submit

March 22, 2011

Conditions

brca1 Mutation Carrierbrca2 Mutation CarrierBreast Cancer

Keywords

breast cancerBRCA1 mutation carrierBRCA2 mutation carrier

Outcome Measures

Primary Outcomes (1)

  • Identification of potential genetic modifiers of breast cancer risk

Interventions

DNA analysisGENETIC
mutation analysisGENETIC
polymorphism analysisGENETIC
laboratory biomarker analysisOTHER
evaluation of cancer risk factorsPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Mark H. Greene, MD

    Clinical Genetics Branch

    STUDY CHAIR

  • Michael Birrer, MD, PhD

    NCI - Cell and Cancer Biology Branch

  • Phuong Mai, MD

    Clinical Genetics Branch

Study Design

Study Type
observational
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

April 1, 2008

Primary Completion

December 1, 2009

Last Updated

March 23, 2011

Record last verified: 2011-03

Locations

US(1)