AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment
ConditionColorectal Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorServicio de Salud Metropolitano Sur Oriente
About this trial
This prospective observational substudy evaluates the association between artificial intelligence-derived features from stool images analyzed using the FAEX Health digital platform and fecal immunochemical test results in adults undergoing colorectal cancer screening or diagnostic evaluation. Participants will capture stool images using a mobile application. The primary analysis will compare AI-derived image outputs with quantitative FIT values and FIT positivity. Secondary exploratory analyses will assess associations with colonoscopy and histopathological findings when these results are available. The platform will be used exclusively for research and will not provide diagnoses, replace clinical evaluation, or influence medical decisions.
Eligibility criteria
Qualifiers
Age 18 years or older.
Referred for screening or diagnostic colonoscopy at Hospital Dr. Sótero del Río.
Quantitative fecal immunochemical testing planned or completed within 30 days before or after stool image submission.
Able to submit at least one stool image using the FAEX Health mobile application, independently or with assistance.
Disqualifiers
Unable or unwilling to provide written informed consent.
Previous enrollment in the study.
Unable to complete stool-image capture, even with assistance.
Study images and clinical data cannot be reliably linked using the assigned study code.
Trial design
Treatments tested in this trial
- AI-Based Stool Image Analysis
Treatment groups
250 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov