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NCT07740122

Overview

NCT ID: NCT07740122
Lead Sponsor: Servicio de Salud Metropolitano Sur OrienteOTHER_GOV
Official Title: FECAL-AI: Prospective Observational Validation of AI-Based Stool Image Analysis Against Quantitative Fecal Immunochemical Testing for Colorectal Neoplasia Risk Assessment
Brief 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

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: May 8, 2026Actual
Primary Completion Date: Dec 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No data available
Eligibility Criteria: 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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 250Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Erik Manriquez Alegria, MDContact
erik.manriquez.alegria@gmail.com

Similar Studies

Participant Group/Arms

Prospective Stool Image, FIT and Colonoscopy Cohort

Adults participating in colorectal cancer screening or diagnostic evaluation who submit stool images through the FAEX Health mobile application. AI-derived stool image outputs will be compared primarily with quantitative fecal immunochemical test results and FIT positivity. Colonoscopy and histopathology findings will be evaluated as secondary exploratory outcomes when available. AI-derived results will not be returned to participants or clinicians and will not influence clinical decisions.

Diagnostic Test: AI-Based Stool Image Analysis