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Understanding Breast Cancer Risk from Benign Breast Disease

This observational study aims to better understand how benign (non-cancerous) breast diseases might lead to breast cancer. Researchers are looking at genetic factors, as well as features seen in pathology reports (from tissue samples) and radiology images (like mammograms). The goal is to improve how breast cancer is diagnosed and treated in the future. You may be able to join if you are a woman between 18 and 100 years old and had a benign breast biopsy at Mayo Clinic between 2002 and 2022. This study is not testing a new drug or intervention; it's about collecting and analyzing existing information. The study plans to include 4500 participants, but its current recruitment status is unclear.

Study design
This is an observational study planning to enroll 4500 women. It is not testing a specific treatment.
What's involved
Participation involves the collection of a blood or saliva sample at baseline to analyze pathologic, radiologic, and molecular features.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07207564

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

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~4,500 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic features
Measured over Baseline (collection of blood or saliva sample)
+2 more outcomes measured

Conditions

Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 2 states
Florida1
Minnesota1

Study leadership

  • Mark E. Sherman, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Laura Pacheco-Spann
[email protected]
904-953-0408
Email the study team

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Eligibility criteria

Inclusion

Female patients, ages 18 to 100 years
Had a benign breast biopsy at Mayo Clinic between 2002-2022

Exclusion

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

What this trial measures

  • Pathologic featuresBaseline (collection of blood or saliva sample)

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

  • Radiologic featuresBaseline (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 featuresBaseline (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