Understanding genetic and environmental factors in breast and ovarian cancers
Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT01034033 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women with known BRCA1/2 mutations or a strong family history of breast or ovarian cancer.
Not a fit: Patients without a genetic predisposition or family history of breast or ovarian cancer may not benefit from this study.
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 performed: Other studies have shown success in understanding genetic factors in cancer, making this approach both relevant and promising.
Eligibility criteria
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 this trial is running
Stanford, California
- Stanford University School of Medicine — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: James M Ford — Stanford University
- Study coordinator: Meredith Mills
- Email: bluett@stanford.edu
- Phone: (650) 724-5223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.