Prediction of Postoperative Recurrence in Crohn's Disease

Prediction Model and Molecular Mechanisms of Postoperative Recurrence in Crohn's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease (CD); Postoperative Recurrence and Metastasis
• Intervention / Treatment: Procedure: Intestinal Resection; Procedure: Biospecimen Collection

Detailed Description

Crohn's disease is characterized by chronic relapsing intestinal inflammation, and a substantial proportion of patients eventually require intestinal resection because of complications such as strictures, penetrating disease, or failure of medical therapy. Postoperative recurrence remains common, but reliable biomarkers and validated prediction models for identifying patients at high risk of recurrence are still lacking.

This is a multicenter, prospective, observational cohort study designed to investigate the predictors and molecular mechanisms of postoperative recurrence in Crohn's disease. The study consists of a screening cohort and a validation cohort. Approximately 200 patients with Crohn's disease undergoing intestinal resection will be enrolled, including 100 participants in the screening cohort and 100 participants in the validation cohort. In addition, approximately 50 patients undergoing intestinal resection for colorectal tumors, diverticular disease, or other non-inflammatory bowel disease conditions will be enrolled as controls.

In the screening cohort, residual surgical specimens that would otherwise be discarded will be collected. Clinical characteristics, follow-up information, biological samples, and multi-omics data will also be collected. Molecular profiling will include analyses such as bulk transcriptomics, single-cell transcriptomics, spatial transcriptomics, proteomics, microbiome analysis, and metabolomics, as applicable. Differences between patients with and without postoperative recurrence will be evaluated, and machine-learning methods will be used to construct a multimodal prediction model.

The validation cohort will be used to evaluate the predictive performance of the multimodal model in a multicenter setting. Postoperative recurrence will be assessed using clinical, endoscopic, and imaging evaluations during follow-up. The study also aims to investigate molecular pathways associated with postoperative recurrence and to identify potential therapeutic targets.

This study is observational. No randomized assignment or protocol-mandated treatment will be provided. Clinical management and postoperative treatment decisions will be made independently by the treating physicians according to routine clinical practice.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Xiang Gao, MD; Phone Number: +86-13502405878; Email: gxiang@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Xiang Gao, MD; Phone Number: +86-13502405878; Email: gxiang@mail.sysu.edu.cn
      • Contact: Email: guoq83@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Procedure: Biospecimen Collection; 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.
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; 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.; Procedure: Biospecimen Collection; 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; 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; 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.; Procedure: Biospecimen Collection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic Recurrence Rate at 1 Year	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.	1 year after intestinal resection
Clinical Recurrence Rate at 1 Year	Clinical recurrence is defined as 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.	1 year after intestinal resection
Imaging Recurrence Rate at 1 Year	Imaging recurrence is defined as a score of 2 or higher on computed tomography enterography (CTE) or magnetic resonance enterography (MRE) after surgical resection of the diseased bowel. The outcome is reported as the proportion of participants meeting the imaging recurrence criterion.	1 year after intestinal resection
Imaging Recurrence Rate at 6 Months	Imaging recurrence is defined as a score of 2 or higher on computed tomography enterography (CTE) or magnetic resonance enterography (MRE) after surgical resection of the diseased bowel. The outcome is reported as the proportion of participants meeting the imaging recurrence criterion.	6 months after intestinal resection
Reoperation or Endoscopic Treatment Rate at 1 Year	The outcome is defined as the proportion of participants who require repeat intestinal resection or endoscopic treatment because of Crohn's disease recurrence after the index intestinal resection. Stoma reversal procedures and surgeries for perianal disease are not counted as outcome events.	1 year after intestinal resection

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: September 12, 2026
• First Submitted That Met QC Criteria: September 12, 2026
• First Posted (Actual): September 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 12, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Prediction Model; Spatial Transcriptomics; Single-Cell Transcriptomics; Postoperative Recurrence; Multimodal Prediction
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Neoplastic Processes; Gastroenteritis; Inflammatory Bowel Diseases; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Crohn Disease
• Other Study ID Numbers: G2025005; 2025ZSLYEC-290 (Other Identifier: Ethics Committee of The Sixth Affiliated Hospital, Sun Yat-sen University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No