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AI reads biopsies to spot Crohn's patients at risk of surgery

NCT ID NCT07795476

Diagnosis Sponsor: PharmaNest, Inc Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

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 Results may not be published yet.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

Expanded access (not trials)

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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

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First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

Researchers are testing whether an artificial intelligence tool can measure fibrosis, or scarring, in intestinal biopsies from people with Crohn's disease. The study will use previously collected biopsy samples and medical records from 100 adults to see if the AI's fibrosis score matches a pathologist's assessment and whether it can predict who later needs surgery. If successful, this digital biomarker could help identify patients at higher risk of disease progression.

What this could mean

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

Active substance
Ph-FCS(Muc), a digital pathology biomarker that uses artificial intelligence to score fibrosis severity from biopsy images
What this could lead to
If it works, this could give doctors a more precise tool to measure fibrosis and identify Crohn's patients at higher risk of needing surgery, potentially guiding earlier or more aggressive treatment.
What could go wrong
This is a retrospective observational study, so it can only show associations, not cause and effect. The biomarker may not prove accurate enough to predict outcomes in real-world settings, and the results depend on the quality of previously collected biopsies.

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 100 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The study population consists of adults (≥18 years) with a diagnosis of Crohn's disease and an available ileal endoscopic biopsy suitable for digital pathology analysis. The overall AIFOR-CD population includes patients spanning varying degrees of mucosal fibrosis and disease characteristics. For the outcomes component, patients without prior gastrointestinal surgery or endoscopic intervention are selected according to whether they underwent a first ileal surgical resection for fibrostenotic Crohn's disease within 6-24 months after the index biopsy or remained free of ileal resection or endoscopic intervention for at least 4 years after the index biopsy.

Ages

18 to 80 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: * Adult pts (\>=18 years old) diagnosed with Crohn's disease based on Investigator's assessment. * Ileal biopsy with fibrosis Masson's Trichome staining available for digitization or already digitized at 40X ( or \~0.25micron per pixel) * The cohort will contain patients with various levels of intensity and distribution of fibrosis as defined by the pathologist with a minimum of 7 patients for any level of intensity and distribution for being required. * Minimum information available for each patient (see Appendix 2, table 1) Exclusion Criteria: * History of gastrointestinal endoscopic interventions and/or surgery for Crohn's disease management such as endoscopic balloon dilation, strictureplasty, stricturectomy or bowel resection prior to the index biopsy. * History of gastrointestinal surgery for any indication

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Conditions

The condition(s) this trial relates to.

Crohn disease Fibrosis

As listed by the trial registrant

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

Crohn disease

How to take part

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  1. The study's own enquiry address

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  2. The places running it

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

  3. The official record

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013, Spain

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