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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Xiang Gao, MD
- Telefoonnummer: +86-13502405878
- E-mail: gxiang@mail.sysu.edu.cn
Studie Locaties
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510655
- Werving
- The Sixth Affiliated Hospital, Sun Yat-sen University
-
Contact:
- Xiang Gao, MD
- Telefoonnummer: +86-13502405878
- E-mail: gxiang@mail.sysu.edu.cn
-
Contact:
- E-mail: guoq83@mail.sysu.edu.cn
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
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:
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:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
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.
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.
|
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.
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.
|
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.
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Clinical Recurrence Rate at 6 Months
Tijdsspanne: 6 months after intestinal resection
|
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
Tijdsspanne: 6 months after intestinal resection
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Endoscopic Recurrence Rate at 1 Year
Tijdsspanne: 1 year after intestinal resection
|
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
Tijdsspanne: 1 year after intestinal resection
|
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
Tijdsspanne: 1 year after intestinal resection
|
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
Tijdsspanne: 6 months after intestinal resection
|
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
Tijdsspanne: 1 year after intestinal resection
|
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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- G2025005
- 2025ZSLYEC-290 (Andere identificatie: Ethics Committee of The Sixth Affiliated Hospital, Sun Yat-sen University)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .