Integrating Molecular Pathology, Radiology, and Genetics to Improve Breast Cancer Risk

Recruiting

• Conditions: Breast Carcinoma

• Registration Number: NCT07207564
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to better understand how benign breast diseases might lead to breast cancer, focusing on genetic factors and including a diverse range of participants to improve future diagnosis and treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-28
• Status Verified: 2025-09
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06
• Primary Completion: 2030-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 4500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiologic features	Baseline (collection of blood or saliva sample)	Will examine radiologic features from mammographic images at time of benign breast disease (BBD), including breast density, soft tissue lesions, multiplicity of calcifications, and asymmetries, associated with risk of BC among women with BBD.
Molecular features	Baseline (collection of blood or saliva sample)	Will use molecular features, including proliferation, immune response, and DNA repair, in combination with pathology and PRS, to predict BC risk among women with BBD.
Pathologic features	Baseline (collection of blood or saliva sample)	Will apply pathologic features from benign tissue assessed microscopically and with validated Artificial Intelligence (AI) approaches in combination with a polygenic risk score (PRS), and a modified, optimized PRS, to predict breast cancer (BC) risk.

Trial Locations

Locations (2)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States