Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples
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ClinicalTrials.gov Identifier: NCT01034033 |
Recruitment Status :
Recruiting
First Posted : December 17, 2009
Last Update Posted : November 4, 2020
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Condition or disease |
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Breast Cancer Ovarian Cancer Gynecologic Cancers Ovarian/Peritoneal/Fallopian Cancer |
- To establish a demographic database to evaluate the efficacy of medical interventions in patients and relatives who carry BRCA1 and 2 mutations and to compare these outcomes to patients who do not carry a BRCA1 or 2 mutation.
- To obtain blood samples from patients who undergo genetic testing to a) evaluate the incidence of genetic modifier polymorphisms involved in the development of cancer in BRCA1 and 2 mutation carriers and to compare this incidence to non-BRCA 1 and 2 carriers. b) to understand the interaction of genetic modifiers and BRCA1 and 2 in the development of cancer. c) to determine the effect of environmental influences on the incidence of polymorphisms in genetic modifiers and on the penetrance of BRCA1 and 2 mutations by linking information from our demographic database to blood samples and
- To obtain tumor tissue from BRCA1 and 2 carriers to utilize for gene expression studies.
- To establish a cohort of sporadic breast cancer patients, or women with no family history of cancer in a first degree relative, to serve as a comparison group to women with strong family history of breast cancer.
- To establish a cohort of healthy volunteers without personal or family history of cancer to serve as a comparison group to women with sporadic and familial breast cancer.
Study Type : | Observational |
Estimated Enrollment : | 3300 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples |
Study Start Date : | August 2001 |
Estimated Primary Completion Date : | January 2099 |
Estimated Study Completion Date : | January 2099 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
I. Women who have a high risk of developing breast or ovarian cancer due to a known germline mutation in the BRCA1/2, PTEN, CDH1, or TP53 cancer susceptibility genes, or due to strong family history of either breast or ovarian cancer, in the absence of known cancer susceptibility gene mutation.
II. Women who are approaching surgery for resection of a pelvic mass, which is considered suspicious for neoplasia by radiologic or clinical criteria; such women may or may not also meet criteria for inclusion in group I.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034033
Contact: Meredith Mills | (650) 724-5223 | bluett@stanford.edu |
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Meredith Mills 650-724-5223 bluett@stanford.edu | |
Principal Investigator: James M Ford | |
Sub-Investigator: Allison Walsh Kurian |
Principal Investigator: | James M Ford | Stanford University |
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT01034033 |
Other Study ID Numbers: |
IRB-11872 SU-11022007-786 ( Other Identifier: Stanford University ) BRSNSTU0020 ( Other Identifier: OnCore ) |
First Posted: | December 17, 2009 Key Record Dates |
Last Update Posted: | November 4, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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