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Breast CancerNCT07214883

UCF MammoChat: Image Repository

An observational study of Breast Cancer and Breast Cancer Awareness, run by University of Central Florida at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
20,000 participants
Where
1 siteUnited States
Study dates
3 Sep 2025to 30 Jun 2026
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amoy Fraser, PhD, CCRP, PMP contact

4072668742

Amoy.Fraser@ucf.edu

Britney-Ann Wray, BS, CTBS, CCRP contact

4072668742

britney-ann.wray@ucf.edu

United States1 site, 1 recruiting
  • University of Central Florida

    Orlando, Florida, 32827

    Amoy Fraser, PhD, CCRP, PMP, 4072668742, britney-ann.wray@ucf.edu

    Britney-Ann Wray, BS, CCRP, CTBS, 4072668742, britney-ann.wray@ucf.edu

    Recruiting

Other trials in United States

About this study

Official title: UCF MammoChat: An AI-Driven Platform for Personalized Breast Cancer Patient Support -Image Repository

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.

Read the detailed description

Breast cancer patients often face overwhelming emotional and practical challenges, from feeling isolated to struggling to find the right information or resources during their treatment and recovery. These barriers can greatly impact both their quality of life and the effectiveness of their care. Among all US women, breast cancer is the second most common cancer and the second most common cause of cancer death. Recent guidelines recommend screening mammography in healthy women starting at 40 years old. The goal of screening mammography is to catch pre-cancerous lesions earlier so there is a high false positive error rate by design to not miss even remotely suspicious lesions on imaging. As evidenced by epidemiological studies, overdiagnosis in breast cancer is now a problem where up to 50% of screened women will have a false positive mammogram interpretation in their lifetime. The psychological impact of the false positivity manifest has significantly increased anxiety among patients that are needlessly recalled for false positive mammogram screening. Moreover, imprecise mammography interpretation may set off a complex cascade of potentially downstream surgical procedures (such as biopsy or mastectomy) for localized disease versus medical interventions such as radiation or chemotherapy for more advanced diseases.

The Health Insurance Portability and Accountability Act (HIPAA) gives patients the right to share their clinical data via informed consent for meaningful use such as research to improve health outcomes. One way of supporting breast cancer patients is by making their mammograms available to them. This allows patients to see and share their images. Some patients may be deterred from obtaining their images from their imaging centers due to cost and as they have no way to view DICOM images. Therefore, this study seeks to provide the mammography images to the participants.

While there are many open-source AI algorithms to improve precision in mammography interpretation, there are widely discrepant outcomes in breast cancer due to a complex and multifactorial disease etiology of different patient populations including social determinants of health. A recent retrospective study found that the integration of AI algorithms performed significantly better than the standard model for predicting breast cancer risk at 0 to 5 years 8. However, the bias in training data used to develop AI has long been recognized as limitations to its widespread application to marginalized populations as recently evidenced by a class action lawsuit against United Healthcare claiming its AI algorithms denied coverage and thus care to black and brown patients at scale 9,10. Moreover, the most cutting-edge algorithms in the current age of generative AI may often make random errors that can be disastrous in a clinical scenario. AI models are not omniscient as there is great variability in humans. AI models may need to be enhanced for different populations (such as different racial groups, ages ranges, or ethnicities) or for different types of breast cancer. Therefore, there is a stark need for accessible patient populations to demonstrate the applicability of robust AI to a diverse US population.

Therefore, using the images that the patients donate, the study aims to build AI models that can better read diagnostic mammograms.

Being tested
No Interventions
Keywords
Breast Cancer, Artificial Intelligence, AI
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionsOther

    No intervention for participants.

Study groups in NCT07214883
Study groupRoleWhat they receive
Breast Cancer PatientsPatients who have a been diagnosed with breast cancer
Receives: Other: No Interventions
ControlsNo breast cancer diagnosis
Receives: Other: No Interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AI model training using mammograms

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

    Measured: 1 year

  2. Provide mammography images to participants

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2025
  2. Study start3 Sep 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
20,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07214883
Sponsor's protocol ID
STUDY00008263
Status last verified
Oct 2025
First submitted
8 Oct 2025
Last updated
9 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Breast Cancer Awareness, run by University of Central Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amoy Fraser, PhD, CCRP, PMP (4072668742, Amoy.Fraser@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AI model training using mammograms (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.

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UCF MammoChat: Image Repository (NCT07214883) | AzTrials