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RecruitingNCT07207564Updated Aug 27, 2026

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

An observational study in Breast Carcinoma, sponsored by Mayo Clinic. Recruiting at 2 sites in United States. Open to female participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,500
Ages
18 Years to 100 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Breast Carcinoma

Browse trials for

03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 4,500 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,500 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherNon-Interventional Study

    Non-interventional study

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

06

What researchers measure

Primary outcomes

  1. Pathologic features

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

    Time frame: Baseline (collection of blood or saliva sample)

  2. 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.

    Time frame: Baseline (collection of blood or saliva sample)

  3. 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

    Time frame: Baseline (collection of blood or saliva sample)

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07207564
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Oct 6, 2025
Start date
Aug 28, 2025
Primary completion
Jun 30, 2030 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Aug 27, 2026

Study contacts

Laura Pacheco-Spann
Contact
pachecospann.laura@mayo.edu
904-953-0408
Clinical Trials Referral Office
Contact
mayocliniccancerstudies@mayo.edu
855-776-0015
Mark E. Sherman, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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