NCT00899145

Brief Summary

This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers. Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors identify biomarkers related to cancer.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 1, 2008

Completed
1 year 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
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

1.7 years

First QC Date

May 9, 2009

Last Update Submit

July 11, 2017

Conditions

BRCA1 Mutation CarrierBRCA2 Mutation CarrierBreast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Identification of potential genetic modifiers of breast cancer risk

    Up to 2 years

Study Arms (1)

Ancillary-Correlative (biomarker sampling and analysis)

Previously collected DNA samples and associated clinical information obtained from BRCA mutation-positive participants enrolled on GOG-0199 are studied. DNA samples are analyzed by mutation testing for variants (i.e., SNPs) in candidate genes of interest. Once genetic testing for a given set of variants has been completed, the coded laboratory data file is merged with selected demographic, clinical, and epidemiological data obtained from the GOG-0199 baseline questionnaire and submitted to the CIMBA Central Database to analyze and publish the data. 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.

Other: Laboratory Biomarker Analysis

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Ancillary-Correlative (biomarker sampling and analysis)

Eligibility Criteria

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

You may qualify if:

  • Women with or without a personal history of breast cancer prior to enrollment in Gynecologic Oncology Group (GOG)-0199
  • Known currently to be BRCA1/2 mutation carrier either by confirmed outside report or by research testing
  • No BRCA1/2 mutation-negative or mutation-unknown status
  • Enrolled on clinical trial GOG-0199 AND meets the following criteria:
  • Completed baseline questionnaire (BQ-199)
  • Provided information on previous breast cancer history, including date of diagnosis
  • Provided complete data from the DNA analysis on the genetic variants of interest
  • Available DNA samples for analysis
  • Hormone receptor status not specified
  • Pre- or post-menopausal status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mark Greene

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

May 1, 2008

Primary Completion

January 1, 2010

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

US(1)