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

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.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Florida, Jacksonville, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

Pathologic features

Time frame: Baseline (collection of blood or saliva sample)

Will examine pathologic features from benign tissue to define features related to breast cancer (BC) risk.
Radiologic features

Time frame: Baseline (collection of blood or saliva sample)

Will examine radiologic features from mammographic images at time of benign breast disease (BBD) to define features in mammogram images that predict BC risk among women who have a history of BBD. We will also assess whether these features predict BC risk among women without a history of BBD.
Molecular features

Time frame: Baseline (collection of blood or saliva sample)

Will examine molecular features to understand how molecular features, including DNA damage and repair work in the breast tissues of women with BBD and how this might relate to risk of developing BC

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2030
First posted: Oct 6, 2025
Registry last updated: Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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