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NCT07757217Completed

Artificial Intelligence-Based Classification and Prognostic Prediction in Small Bowel Crohn's Disease

Establishment and Application of an Artificial Intelligence-Driven Precision Classification and Prognostic Prediction System for Small Bowel Crohn's Disease

Source: ClinicalTrials.gov · Last updated 11 Aug 2026

Brief summary (registry, in English)

This retrospective observational study aims to develop an artificial intelligence-based system for the precise classification and prognostic prediction of small bowel Crohn's disease. The study includes 437 patients with Crohn's disease who were hospitalized at Shanghai Tenth People's Hospital between January 1, 2020, and January 31, 2025. Clinical information, laboratory results, endoscopic findings, computed tomography enterography or magnetic resonance enterography images, and available pathological and molecular data will be collected from existing medical records. Artificial intelligence-based image segmentation and multimodal analysis will be used to identify and quantify intestinal lesions, strictures, mesenteric changes, fistulas, abscesses, and other disease characteristics. The study will examine whether these features can classify patients more accurately and predict clinical outcomes, including response to medical treatment, treatment failure or switching, and the need for surgery. The resulting system may support individualized assessment and clinical decision-making for patients with small bowel Crohn's disease.

Status (registry)
Completed
Study type
Observational
Enrollment
437 (actual)
First submitted
6 Aug 2026
Start date
1 Jan 2020
Primary completion date
31 Oct 2025
Lead sponsor
Shanghai 10th People's Hospital
NCT number
NCT07757217

What you commit to

  • Study type: Observational
  • Participants enrolled: 437
  • From 1 Jan 2020 to the primary completion date, 31 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Failure to receive regular medical treatment or follow-up.
  • Presence of a malignant tumor.
  • Presence of severe comorbidities, including heart failure or other severe organ dysfunction, that may substantially affect clinical outcomes.

Lab values

  • Incomplete clinical or laboratory data that prevent assessment of the prespecified variables or clinical outcomes.

Other

  • Poor-quality or incomplete CTE or MRE images that prevent reliable image segmentation or evaluation.

Who the study is looking for

  • Diagnosis of Crohn's disease established according to the European Crohn's and Colitis Organisation criteria based on clinical, endoscopic, radiological, and/or histopathological findings.
  • Small bowel involvement confirmed by computed tomography enterography, magnetic resonance enterography, endoscopy, surgery, and/or histopathology.
  • Availability of CTE or MRE images obtained before treatment and during follow-up. Follow-up imaging was performed within 6 months after treatment for patients with active disease or within 1 to 2 years for patients in remission.
  • Availability of sufficient clinical and follow-up information to determine treatment response, treatment switching, or Crohn's disease-related surgery.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Tenth People's Hospital of Shanghai
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.