FECAL-AI: Prospective Observational Validation of AI-Based Stool Image Analysis Against Quantitative Fecal Immunochemical Testing for Colorectal Neoplasia Risk Assessment
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.
• 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.
• Able and willing to provide written informed consent.