AI-powered stool image analysis to see if it matches FIT results in colorectal cancer screening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational substudy focusing on adults undergoing colorectal cancer screening or diagnostic evaluation. Participants take stool images with the FAEX Health mobile app, which are analyzed by AI algorithms to extract visual features. The study compares AI outputs with quantitative FIT values and FIT positivity, and explores associations with colonoscopy and histopathology when available. Researchers will keep AI results non-diagnostic and separate from clinical decisions, and personal identifiers will be kept separate from the images. This substudy builds on a broader project and aims to inform future work on stool-image-based triage strategies rather than replace FIT.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Hospital Sotero del Rio
  Santiago, Santiago Metropolitan, Chile Recruiting

Study contacts

• Principal investigator: Erik Manriquez Alegria, MD — Hospital Sotero Del Rio
• Study coordinator: Erik Manriquez Alegria, MD
• Email: erik.manriquez.alegria@gmail.com
• Phone: +56988232111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.