NCT07740122Recruiting
AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment
FECAL-AI: Prospective Observational Validation of AI-Based Stool Image Analysis Against Quantitative Fecal Immunochemical Testing for Colorectal Neoplasia Risk Assessment
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 28 Jul 2026
- Start date
- 8 May 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Servicio de Salud Metropolitano Sur Oriente
- Diseases
- Colorectal cancer
- NCT number
- NCT07740122
What you commit to
- Study type: Observational
- Planned participants: 250
- From 8 May 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous enrollment in the study.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Sotero del Rio Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.