Combining tissue, imaging, and genetic information to improve breast cancer risk prediction
Integrating Molecular Pathology, Radiology, and Genetics to Improve Breast Cancer Risk
This research tests whether combining pathology, radiology, and genetic data can better predict future breast cancer risk for women who previously had a benign breast biopsy at Mayo Clinic.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT07207564 on ClinicalTrials.gov |
What this trial studies
This observational project analyzes tissue samples, imaging, and genetic data from women who had benign breast biopsies at Mayo Clinic between 2002 and 2022. Researchers will link pathology features, radiology reports/images, and genetic information to identify patterns associated with later development of breast cancer. The cohort is intended to be diverse and uses existing medical records and archived tissue rather than interventional procedures. Results will be used to improve risk models and inform future screening or prevention strategies.
Who should consider this trial
Good fit: Women aged 18–100 who had a benign breast biopsy at Mayo Clinic between 2002 and 2022, have no prior or concurrent breast cancer diagnosis, and provide research authorization are ideal candidates.
Not a fit: Men, people with prior or concurrent breast cancer (including cancer diagnosed within six months of the benign biopsy), those who had bilateral prophylactic mastectomy around the biopsy time, or anyone whose benign biopsy was not performed at Mayo Clinic during the specified years are unlikely to benefit.
Why it matters
Potential benefit: If successful, the work could help identify women at higher risk after a benign biopsy so they can receive earlier screening or preventive care.
How similar studies have performed: Previous studies have linked benign breast conditions, imaging features, and genetic markers to cancer risk, but integrating molecular pathology, radiology, and genetics in a large linked cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients, ages 18 to 100 years * Had a benign breast biopsy at Mayo Clinic between 2002-2022 Exclusion Criteria: * All male patients * Prior or concomitant diagnosis of BC * Diagnosis of BC within six months of benign breast disease * Denial of research authorization * Concurrent or post-biopsy bilateral prophylactic mastectomy
Where this trial is running
Jacksonville, Florida and 1 other locations
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Mark E. Sherman, MD — Mayo Clinic
- Study coordinator: Laura Pacheco-Spann
- Email: pachecospann.laura@mayo.edu
- Phone: 904-953-0408
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.