AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment
Recruiting now
Conditions studied: Colorectal Neoplasms
In brief
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.
Key facts
- Study ID
- NCT07740122
- Run by
- Servicio de Salud Metropolitano Sur Oriente
- People needed
- 250
- Starts
- 2026-05-08
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Hospital Sotero del Rio — Santiago, Santiago Metropolitan, Chile (enrolling)
Full record on ClinicalTrials.gov
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