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AI may predict ulcerative colitis severity before a scope — a study puts it to the test

NCT ID NCT07721987

Knowledge-focused Sponsor: Beijing University of Chinese Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 23, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This study is testing whether a machine learning model can predict the extent of ulcerative colitis (UC) in the colon using only symptoms, physical signs, and lab results — before a colonoscopy is done. Researchers will analyze data from 1,500 people with UC to build and validate the model. If it works, it could provide an early estimate of disease spread, but it is not designed to replace colonoscopy or biopsy.

What this could mean

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

What this could lead to
If successful, this model could help doctors estimate disease extent earlier, potentially guiding treatment decisions before a colonoscopy.
What could go wrong
This is an observational study, not a treatment trial. The model may not be accurate enough for real-world use and is not meant to replace colonoscopy.

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 1,500 people

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

Started

Nov 2015

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 with UC from four hospitals in China (2020-2025). Development cohort: Centers A (Dongfang Hospital, BUCM) and B (Dongzhimen Hospital, BUCM). External validation cohort: Centers C (BUCM Third Affiliated Hospital) and D (Yantai Hospital of Traditional Chinese Medicine).

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Confirmed diagnosis of ulcerative colitis by endoscopy ± histopathology. 2. Montreal disease extent classifiable as E1 (limited), E2 (intermediate/left-sided), or E3 (extensive) and mapped to study labels 1/2/3. 3. Pre-endoscopic baseline data available: demographics, symptoms, signs, and laboratory tests used as model predictors. 4. Predictors collected before or independent of endoscopic findings used for the outcome label (endoscopic extent not used as input). 5. One index visit per patient (duplicate/non-index visits excluded). Exclusion Criteria: 1. Non-UC diagnosis or Montreal extent not assignable. 2. Missing patient identifier/linkage or unlabelable outcome. 3. Incomplete endoscopic gold standard for Montreal extent classification. 4. Duplicate or non-index visits. 5. Critical predictor data unavailable and not handled by the prespecified modeling pipeline

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis (disorder)

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