Artificial Intelligence-Based Classification and Prognostic Prediction in Small Bowel Crohn's Dis… (NCT07757217) | Clinical Trial Compass
CompletedNot Applicable
Artificial Intelligence-Based Classification and Prognostic Prediction in Small Bowel Crohn's Disease
China437 participantsStarted 2020-01-01
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Failure to receive regular medical treatment or follow-up.
* Incomplete clinical or laboratory data that prevent assessment of the prespecified variables or clinical outcomes.
* Poor-quality or incomplete CTE or MRE images that prevent reliable image segmentation or evaluation.
* Presence of a malignant tumor.
* Presence of severe comorbidities, including heart failure or other severe organ dysfunction, that may substantially affect clinical outcomes.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Discriminative Performance of the Artificial Intelligence-Based Multimodal Model for Predicting 12-Month Clinical Outcomes
Timeframe: Within 12 months after the index CTE or MRE examination