NCT07740122 AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment
| NCT ID | NCT07740122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Servicio de Salud Metropolitano Sur Oriente |
| Condition | Colorectal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2026-05-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Erik Manriquez Alegria, MD
PRINCIPAL INVESTIGATOR
Hospital Sotero Del Rio
Frequently Asked Questions
Who can join the NCT07740122 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07740122 currently recruiting?
Yes, NCT07740122 is actively recruiting participants. Contact the research team at erik.manriquez.alegria@gmail.com for enrollment information.
Where is the NCT07740122 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT07740122 clinical trial?
NCT07740122 is sponsored by Servicio de Salud Metropolitano Sur Oriente. The principal investigator is Erik Manriquez Alegria, MD at Hospital Sotero Del Rio. The trial plans to enroll 250 participants.