Recruiting

Benign Breast Diseases

Sponsor:

Mayo Clinic

Code:

NCT07207564

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Non-Interventional Study

Study Details

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

Study ID

NCT07207564

Start date

Aug 28, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

4500 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

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

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Pathologic features [ Time Frame: Baseline (collection of blood or saliva sample) ]
  • Radiologic features [ Time Frame: Baseline (collection of blood or saliva sample) ]
  • Molecular features [ Time Frame: Baseline (collection of blood or saliva sample) ]

Central Contacts and Locations

Central contacts

Laura Pacheco-Spann

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

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Laura Pacheco-Spann

904-953-0408PachecoSpann.Laura@mayo.edu

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Mark E. Sherman, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Laura Pacheco-Spann

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

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Celine M. Vachon, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-27.