Combining tissue, imaging, and genetic information to improve breast cancer risk prediction
Official title: Integrating Molecular Pathology, Radiology, and Genetics to Improve Breast Cancer Risk
Run by Mayo Clinic · NCT07207564 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | Women only |
| Enrollment | 4500 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Status | Recruiting |
| Started | August 28, 2025 |
| Main results expected | June 30, 2030 |
| Study ends | June 30, 2030 |
| Registry record updated | August 27, 2026 |
| Trial ID | NCT07207564 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Mobile health navigation to improve breast cancer screening in Kenyan women
This study tests m-Health patient navigation tools to help women in Kenya access breast cancer screening and early detection services.
-
Blended e-Health Program to Help Women with Breast or Gynecologic Cancer Manage Fear of Cancer Progression
This trial tests a blended online and group program to see if it helps women with breast or gynecologic cancer feel less fear that their cancer could grow or spread.
-
Environmental exposure checks in high-risk and early-onset breast cancer care
This study tests how patients and providers feel about using environmental exposure risk data in breast cancer care for women at average/high risk or with early-onset breast cancer.
-
CSF sample collection from people with metastatic breast cancer to see brain metastasis risk
This study tests whether spinal fluid and other samples can help predict brain metastases in adults with metastatic HER2-positive or triple-negative breast cancer who have not yet shown brain involvement.
-
Body composition and outcomes after breast reconstruction
This study will see if detailed body composition measurements can help predict complications after mastectomy with immediate breast reconstruction in adult women.
-
Support tool for women with HR+ breast cancer on long-term endocrine therapy
This study tests a SHIELD web- and app-based portal to help women with hormone receptor–positive breast cancer manage symptoms while on long-term endocrine treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.