Testing whether stool photos analyzed by AI can help assess colorectal cancer risk
Compares AI analysis of stool photos with stool blood test results in adults.
Plain-language title generated from the registry record
Registry title: AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment
Key facts
- Where
- Santiago, ChileSee the site
Where in Chile
- Hospital Sotero del RioSantiago, ChileTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Servicio de Salud Metropolitano Sur Oriente
- Trial code
- NCT07740122
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Previous enrollment in the study; Unable or unwilling to provide written informed consent; Unable to complete stool-image capture, even with assistance; Study images and clinical data cannot be reliably linked using the assigned study code.