Prediction of Postoperative Recurrence in Crohn's Disease

NCT07824791 | Recruiting

• 2 other identifiers: G20250052025ZSLYEC-290
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter prospective observational cohort study aims to develop and validate a multimodal prediction model for postoperative recurrence in patients with Crohn's disease. Patients with Crohn's disease who undergo intestinal resection will be enrolled and followed after surgery. Residual surgical tissue that would otherwise be discarded, together with routinely collected clinical data and biological samples, will be used for research. Multi-omics analyses, including single-cell transcriptomics and spatial transcriptomics, will be performed to identify biological features associated with postoperative recurrence. Participants with Crohn's disease will be followed for clinical, endoscopic, and imaging recurrence after surgery. The study will use data from a screening cohort to develop a prediction model and a validation cohort to evaluate the performance of the model. A control group consisting of patients undergoing intestinal resection for conditions such as colorectal tumors or diverticular disease will also be included for comparative molecular analyses. No treatment will be assigned by the study protocol. All treatment decisions will be made by the treating physicians according to routine clinical practice.

Conditions

Postoperative Recurrence and Metastasis; Crohn Disease (CD)

Keywords

Postoperative Recurrence; Prediction Model; Multimodal Prediction; Single-Cell Transcriptomics; Spatial Transcriptomics

Outcome Measures

Primary Outcomes (2)

• Clinical Recurrence Rate at 6 Months

  Clinical recurrence is defined as the recurrence of clinical manifestations or complications such as abdominal pain, diarrhea, hematochezia, fistula, or perforation, together with a Harvey-Bradshaw Index (HBI) \>4 or Crohn's Disease Activity Index (CDAI) \>150, with recurrence confirmed by endoscopic or imaging assessment. The outcome is reported as the proportion of participants with clinical recurrence.

  6 months after intestinal resection

• Endoscopic Recurrence Rate at 6 Months

  Endoscopic recurrence is defined as a Rutgeerts score of i2 or higher on postoperative endoscopy after complete resection of macroscopically diseased bowel. The outcome is reported as the proportion of participants meeting the criterion for endoscopic recurrence.

  6 months after intestinal resection

Secondary Outcomes (5)

• Endoscopic Recurrence Rate at 1 Year

  1 year after intestinal resection

• Clinical Recurrence Rate at 1 Year

  1 year after intestinal resection

• Imaging Recurrence Rate at 1 Year

  1 year after intestinal resection

• Imaging Recurrence Rate at 6 Months

  6 months after intestinal resection

• Reoperation or Endoscopic Treatment Rate at 1 Year

  1 year after intestinal resection

Study Arms (3)

Screening Cohort

Patients with Crohn's disease undergoing clinically indicated intestinal resection. Approximately 100 participants will be enrolled in this cohort. Residual surgical tissue, clinical characteristics, biological samples, and multi-omics data will be collected. Participants will be followed after surgery to identify clinical, endoscopic, and imaging recurrence. Data from this cohort will be used to identify molecular features associated with postoperative recurrence and to develop a multimodal prediction model.

Procedure: Intestinal Resection; Procedure: Biospecimen Collection

Validation Cohort

Patients with Crohn's disease undergoing clinically indicated intestinal resection. Approximately 100 participants will be enrolled in this multicenter validation cohort and followed after surgery. Clinical, endoscopic, imaging, and biological data will be collected to evaluate the predictive performance of the multimodal model developed in the screening cohort.

Procedure: Intestinal Resection; Procedure: Biospecimen Collection

Non-IBD Control Cohort

Patients without inflammatory bowel disease who undergo clinically indicated intestinal resection for conditions such as colorectal tumors or diverticular disease. Approximately 50 participants will be enrolled. Residual surgical tissue that would otherwise be discarded will be collected for comparative molecular and multi-omics analyses.

Procedure: Intestinal Resection; Procedure: Biospecimen Collection

Interventions

Intestinal Resection PROCEDURE

Participants undergo intestinal resection as clinically indicated as part of routine medical care. The surgical procedure is not assigned by the study protocol. Residual surgical tissue that would otherwise be discarded may be collected for research analyses.

Non-IBD Control Cohort; Screening Cohort; Validation Cohort

Biospecimen Collection PROCEDURE

Residual surgical tissue and biological samples are collected for research. Surgical tissue used for research consists of residual specimens remaining after routine clinical pathological examination. Samples may be used for transcriptomic, single-cell transcriptomic, spatial transcriptomic, proteomic, microbiome, metabolomic, and other multi-omics analyses.

Non-IBD Control Cohort; Screening Cohort; Validation Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Crohn's Disease Cohorts:
• Diagnosis of Crohn's disease according to the diagnostic criteria of the Chinese Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing).
• 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:
• Patients who require surgical resection of an intestinal segment because of conditions such as colorectal tumors or diverticular disease.

You may not qualify if:

• Crohn's Disease Cohorts:
• Uncertain diagnosis of Crohn's disease.
• 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:
• Coexisting inflammatory bowel disease or other rheumatic or autoimmune diseases.
• Substantially incomplete clinical history or medical records.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiang Gao, MD

CONTACT

+86-13502405878; gxiang@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Gastroenterology

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 17, 2026
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)