Clinical trial · Observational
Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers
Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers
NCT00899145CI-TRIAL-00028602withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Mutation Carrier | — | UNRESOLVED | — |
| BRCA2 Mutation Carrier | — | UNRESOLVED | — |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (biomarker sampling and analysis)
- description
- 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.
- interventionNames
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- Identification of potential genetic modifiers of breast cancer risk
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:
* 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 statusReferences
Publications (0)
Data not yet available
No reference posted for this study.