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

NCT ID: NCT07207564

Last Updated: 2025-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-28

Study Completion Date

2030-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Other Intervention Names

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Non-Interventional Observational Study Noninterventional (Observational) Study

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark E. Sherman, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Laura Pacheco-Spann

Role: CONTACT

904-953-0408

Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Facility Contacts

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Laura Pacheco-Spann

Role: primary

904-953-0408

Clinical Trials Referral Office

Role: backup

855-776-0015

Laura Pacheco-Spann

Role: primary

904-953-0408

Clinical Trials Referral Office

Role: backup

855-776-0015

Other Identifiers

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NCI-2025-06873

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-009436

Identifier Type: OTHER

Identifier Source: secondary_id

23-009436

Identifier Type: -

Identifier Source: org_study_id

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