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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07207564
Enrollment
4500
Registered
2025-10-06
Start date
2025-08-28
Completion date
2030-06-30
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

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.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

Countries

United States

Contacts

CONTACTLaura Pacheco-Spann
pachecospann.laura@mayo.edu904-953-0408
CONTACTClinical Trials Referral Office
mayocliniccancerstudies@mayo.edu855-776-0015
PRINCIPAL_INVESTIGATORMark E. Sherman, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026