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

NCT07207564 | Recruiting

• 2 other identifiers: 23-009436NCI-2025-06873
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (3)

• Pathologic features

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

  Baseline (collection of blood or saliva sample)

• Radiologic features

  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.

  Baseline (collection of blood or saliva sample)

• Molecular features

  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

  Baseline (collection of blood or saliva sample)

Study Arms (1)

Observational

Participants complete a questionnaire, undergo collection of saliva or blood samples, and have their medical records reviewed on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study

Observational

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who had a benign breast biopsy at Mayo Clinic between 2002 and 2022.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Deidentified samples will be stored for future research

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark E. Sherman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Pacheco-Spann

CONTACT

904-953-0408; pachecospann.laura@mayo.edu

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 6, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)