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AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment

NCT07740122 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-07-31

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Neoplasms

Interventions

DIAGNOSTIC_TEST

AI-Based Stool Image Analysis

Participants capture stool images using the FAEX Health mobile application. Coded images are analyzed using artificial intelligence algorithms to derive visual features and a prespecified patient-level output or score. The AI-derived output is used exclusively for research and is compared primarily with quantitative FIT results and FIT positivity, with secondary comparisons against colonoscopy and histopathology when available. The output is not used to provide a diagnosis or guide clinical management.

Sponsors & Collaborators

  • Servicio de Salud Metropolitano Sur Oriente

    lead OTHER_GOV

Principal Investigators

  • Erik Manriquez Alegria, MD · Hospital Sotero Del Rio

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-08
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07740122 on ClinicalTrials.gov