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.
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
- Conditions the study is for
- Breast Cancer, Breast Cancer Awareness, Breast Cancer Detection
- 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.
United States1 site, 1 recruiting
- 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
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.
- Conditions
- Breast Cancer, Breast Cancer Awareness, Breast Cancer Detection, Breast Cancer Survivors, Breast Cancer Female, Breast Cancer Diagnosis
- 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 group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients | Patients who have a been diagnosed with breast cancer Receives: Other: No Interventions | |
| Controls | No breast cancer diagnosis Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
AI model training using mammograms
Train, test and validate AI models with de-identified mammograms collected from imaging facilities.
Measured: 1 year
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.
- First posted9 Oct 2025
- Study start3 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Sponsor
- Investigators
- Jane Gibson, PhD, Principal investigator, University of Central Florida
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UCF MammoChat: An AI-Driven Platform for Personalized Breast Cancer Patient Support -Image Repository
- ClinicalTrials.gov ID
- NCT07214883
- Acronym / sponsor ID
- STUDY00008263
- Conditions
- Breast Cancer, Breast Cancer Awareness, Breast Cancer Detection, Breast Cancer Survivors, Breast Cancer Female, Breast Cancer Diagnosis
- Keywords
- Breast Cancer, Artificial Intelligence, AI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients | – | Other: No InterventionsPatients who have a been diagnosed with breast cancer |
| Controls | – | Other: No InterventionsNo breast cancer diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Minors , ages under 18
- Prisoners
- Adults who are unable to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsNo intervention for participants. | Other | Breast Cancer Patients, Controls |
Primary outcome
AI model training using mammograms
Time frame: 1 year
Train, test and validate AI models with de-identified mammograms collected from imaging facilities.
Provide mammography images to participants
Time frame: 1 year
Once images are received, participant will have access to view their mammograms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jane Gibson, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
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.