Clinical trial NCT06604078: Breast Cancer AI Imaging Study
Official title: Elucidating the Impact of Social Wellness and Artificial Intelligence on the Psychological Consequences of Breast Cancer Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Breast Cancer Screening
Keywords: Breast Cancer
Artifical Inteligence
AI
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_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.

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. The investigator will establish a Discourse social network where patients can anonymously and securely share their breast imaging and interact with other patients.
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. 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.

Detailed description: With over 40,000,000 mammograms run annually in the US, there are psychological consequences of breast cancer imaging that are well documented among patients such as stress and anxiety from largely false positive or indeterminant readings by radiologists.

This UCF MammoChat platform is one of the first projects that engages patients to donate their breast cancer imaging in an effort to reduce the psychological consequences of breast cancer imaging using social networks and artificial intelligence.

This repository will be supported and maintained by the University of Central Florida College of Medicine (UCF COM) Clinical and Aerospace Research team. These clinical research coordinators will operate the repository, including administering patients, imaging sites and transfers through an administrative panel.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: AI Model Development
timeFrame: 25 years
measure: Psychological Impact of Breast Cancer Screening
timeFrame: 25 years
measure: Social Discourse for Patients on Wellness Network
timeFrame: 25 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Dexter Hadley, M.D., PhD, M.S.E
role: PRINCIPAL_INVESTIGATOR
References: