Can tissue clues predict which Crohn's patients relapse after surgery?

NCT ID NCT07824791

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Recruitment status, easiest to join first

Recruiting now This study
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Not yet recruiting
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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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The trial has finished. Results may not be published yet.
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Cancelled before anyone took part.

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Not a trial. The treatment could once be requested outside a study, but no longer can.
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When the status isn't known

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First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are building a tool to predict which Crohn's disease patients will have their disease return after intestinal surgery. The study follows 250 people who undergo intestinal resection as part of routine care, collecting leftover surgical tissue, clinical data, and blood or stool samples. Using advanced molecular analyses, the team looks for biological features linked to recurrence and tests whether a prediction model can identify high-risk patients. A comparison group of patients having intestinal surgery for other conditions helps researchers tell Crohn's-specific signals apart from general surgical changes.

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 the model works, doctors could one day estimate a Crohn's patient's risk of relapse after surgery and tailor monitoring or treatment to those most likely to need it.
What could go wrong
This is an observational study with no assigned treatment, so it cannot prove that acting on the model changes outcomes. Prediction models built in one group of patients often perform worse in others, and the molecular findings may not translate into practical tests.

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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

Jul 2025

Expected to finish

Jun 2029

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

Hospitalized or outpatient patients who require intestinal resection will be screened by the investigators. The study population includes patients with Crohn's disease undergoing clinically indicated intestinal resection and non-IBD control participants undergoing intestinal resection for conditions such as colorectal tumors or diverticular disease. Patients with Crohn's disease will be enrolled into a screening cohort or a multicenter validation cohort.

Ages

18 to 70 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: * Crohn's Disease Cohorts: 1. Diagnosis of Crohn's disease according to the diagnostic criteria of the Chinese Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing). 2. Patients with Crohn's disease who require surgical resection of the diseased intestinal segment because of complications such as stricturing or penetrating disease, or because of failure of medical therapy. Non-IBD Control Cohort: 1.Patients who require surgical resection of an intestinal segment because of conditions such as colorectal tumors or diverticular disease. Exclusion Criteria: * Crohn's Disease Cohorts: 1. Uncertain diagnosis of Crohn's disease. 2. Clinical history or medical records are substantially incomplete, making it impossible to determine the time of recurrence or whether postoperative recurrence occurred. Non-IBD Control Cohort: 1. Coexisting inflammatory bowel disease or other rheumatic or autoimmune diseases. 2. Substantially incomplete clinical history or medical records.

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Conditions

The condition(s) this trial relates to.

Crohn disease Neoplasm Metastasis

As listed by the trial registrant

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

How to take part

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  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510655, China

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