NCT06604078

Brief Summary

This study aims to develop a social health platform called MammoChat (https://MammoChat.com) that allows patients to share their real-world patient data to a trusted network for development of clinical intelligence to improve patient outcomes. Therefore:

  1. 1.The investigator will establish a Discourse social network where patients can anonymously and securely share their breast imaging and interact with other patients.
  2. 2.The investigator will use standardized questionnaires to understand the impact of use of the social network on outcomes related to breast cancer screening such as anxiety.
  3. 3.The investigator will assemble a crowdsourced, de-identified radiographic repository for training, testing, and validating AI models aimed at earlier and more accurate disease detection for breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 5, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

September 9, 2024

Last Update Submit

September 11, 2025

Conditions

Keywords

Breast CancerArtifical InteligenceAI

Outcome Measures

Primary Outcomes (3)

  • AI Model Development

    Train, test and validate AI models with de-identified radiographic images collected from participants.

    25 years

  • Psychological Impact of Breast Cancer Screening

    Assess user anxiety using the standardized COS-BC (Consequences of Screening in Breast Cancer) questionnaire.

    25 years

  • Social Discourse for Patients on Wellness Network

    Assess patient participation on Discourse social network using standardized user metrics such as activity logs, images posted, other interactions, etc.

    25 years

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. Potential participants will not be screened for eligibility. In the informed consent process, participants will self-disclose if they have done breast cancer imaging at a US institution. Pregnant women may choose to participate in the repository.

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

You may not qualify if:

  • Minors , ages under 18
  • Prisoners. Given the repository design, prisoners are unlikely to participate and provide a consent
  • 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

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dexter Hadley, M.D., PhD, M.S.E

    University of Central Florida

    PRINCIPAL INVESTIGATOR

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

September 9, 2024

First Posted

September 19, 2024

Study Start

September 5, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations