NCT07214883

Brief Summary

This study aims to develop AI models to better read diagnostic mammograms for various populations and types of breast cancer, using the images that participants donate and their responses from study questionnaire to improve patient outcomes. This study also aims to provide mammography images to participants.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Sep 2025Jun 2026

Study Start

First participant enrolled

September 3, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

October 8, 2025

Last Update Submit

October 8, 2025

Conditions

Keywords

Breast CancerArtificial IntelligenceAI

Outcome Measures

Primary Outcomes (2)

  • AI model training using mammograms

    Train, test and validate AI models with de-identified mammograms collected from imaging facilities.

    1 year

  • Provide mammography images to participants

    Once images are received, participant will have access to view their mammograms.

    1 year

Study Arms (2)

Breast Cancer Patients

Patients who have a been diagnosed with breast cancer

Other: No Interventions

Controls

No breast cancer diagnosis

Other: No Interventions

Interventions

No intervention for participants.

Breast Cancer PatientsControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be enrolled online from across the US. All study procedures are completed online. Potential participants will not be screened for eligibility.

You may qualify if:

  • Adults, ages 18 and older
  • Had a radiographic breast cancer imaging test, either for screening or diagnosis of breast cancer, with either positive or negative results performed in a US institution.
  • Have an email account with access to a reliable internet connection or smartphone
  • Pregnant women may choose to participate.

You may not qualify if:

  • Minors , ages under 18
  • Prisoners
  • Adults who are unable to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32827, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jane Gibson, PhD

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amoy Fraser, PhD, CCRP, PMP

CONTACT

Britney-Ann Wray, BS, CTBS, CCRP

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2025

First Posted

October 9, 2025

Study Start

September 3, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

October 9, 2025

Record last verified: 2025-10

Locations