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Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

Understanding genetic and environmental factors in breast and ovarian cancers

Official title: Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples

Run by Stanford University · NCT01034033 · Data updated 2026-11-12

This study is trying to understand how genes and the environment affect breast and ovarian cancers in people with BRCA1 and BRCA2 mutations to see how different treatments work for them compared to others.

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Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment3300 (estimated)
SponsorStanford University
Academic / other
Locations1 site (Stanford, California)
StatusRecruiting
StartedAugust 2001
Main results expectedJanuary 2099
Study endsJanuary 2099
Registry record updatedMay 18, 2026
Trial IDNCT01034033 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include women with known BRCA1/2 mutations or a strong family history of breast or ovarian cancer.

Probably not a fit

Patients without a genetic predisposition or family history of breast or ovarian cancer may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the biology of breast, ovarian, fallopian tube, peritoneal, and endometrial cancers in individuals at high genetic risk, particularly those with BRCA1 and BRCA2 mutations. It will establish a demographic database to evaluate the efficacy of medical interventions and compare outcomes between mutation carriers and non-carriers. Blood samples will be collected to study genetic modifiers and their interaction with BRCA mutations, while tumor tissue will be analyzed for gene expression. Additionally, cohorts of sporadic breast cancer patients and healthy volunteers will be established for comparative analysis.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cancer development and improve treatment strategies for patients at high genetic risk.

How similar studies have gone: Other studies have shown success in understanding genetic factors in cancer, making this approach both relevant and promising.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Stanford University School of Medicine
    Stanford, California, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.