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Could a smartphone photo of stool help detect colon cancer?

NCT ID NCT07740122

Diagnosis Sponsor: Servicio de Salud Metropolitano Sur Oriente Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This study is testing whether artificial intelligence can analyze photos of stool to help assess colorectal cancer risk. Adults referred for a colonoscopy will take pictures of their stool using a mobile app, and the AI's analysis will be compared with standard fecal immunochemical test (FIT) results. The goal is to see if AI image analysis could serve as a non-invasive screening tool, though it is not intended to replace clinical diagnosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-based stool image analysis using the FAEX Health mobile application
What this could lead to
If successful, this could lead to a non-invasive, at-home screening tool for colorectal cancer risk, potentially reducing the need for invasive procedures.
What could go wrong
This is an observational study, so it won't prove the AI can replace standard tests. The AI output is for research only and may not be accurate enough for clinical use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults receiving care at Hospital Dr. Sótero del Río who are undergoing colorectal cancer screening or diagnostic evaluation and have a quantitative fecal immunochemical test planned or completed. Eligible participants will prospectively submit stool images through the FAEX Health mobile application. AI-derived image features will be compared primarily with matched quantitative FIT results and FIT positivity. Colonoscopy and histopathology findings will be evaluated as secondary exploratory outcomes when available. AI results will not be returned to participants or clinicians and will not influence clinical management.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Sotero del Rio

    RECRUITING

    Santiago, Santiago Metropolitan, 8207257, Chile

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