Crohn Disease (CD)NCT07824791
Prediction of Postoperative Recurrence in Crohn's Disease
An observational study of Crohn Disease (CD) and Postoperative Recurrence and Metastasis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn Disease (CD), Postoperative Recurrence and Metastasis
- What is being tested?
- Intestinal Resection and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2025to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Xiang Gao, MD, +86-13502405878, gxiang@mail.sysu.edu.cn
guoq83@mail.sysu.edu.cn
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Intestinal Resection, Biospecimen Collection
- Keywords
- Postoperative Recurrence, Prediction Model, Multimodal Prediction, Single-Cell Transcriptomics, Spatial Transcriptomics
- Medical subject headings
- Crohn Disease, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal ResectionProcedure or surgery
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.
Biospecimen CollectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Intestinal Resection; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months after intestinal resection
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year after intestinal resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start22 Jul 2025
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Gao, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824791
- Sponsor's protocol ID
- G2025005
- Other IDs
- 2025ZSLYEC-290
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model and Molecular Mechanisms of Postoperative Recurrence in Crohn's Disease
- ClinicalTrials.gov ID
- NCT07824791
- Acronym / sponsor ID
- G2025005
- Keywords
- Postoperative Recurrence, Prediction Model, Multimodal Prediction, Single-Cell Transcriptomics, Spatial Transcriptomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening Cohort | – | Procedure: Intestinal Resection, Procedure: Biospecimen CollectionPatients 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. |
| Validation Cohort | – | Procedure: Intestinal Resection, Procedure: Biospecimen CollectionPatients 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. |
| Non-IBD Control Cohort | – | Procedure: Intestinal Resection, Procedure: Biospecimen CollectionPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Crohn's Disease Cohorts:
- 1.Patients who require surgical resection of an intestinal segment because of conditions such as colorectal tumors or diverticular disease.
Key exclusion criteria (6 listed)
- Crohn's Disease Cohorts:
- Coexisting inflammatory bowel disease or other rheumatic or autoimmune diseases.
- Substantially incomplete clinical history or medical records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal ResectionParticipants 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 or surgery | Non-IBD Control Cohort, Screening Cohort, Validation Cohort |
| Biospecimen CollectionResidual 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. | Procedure or surgery | Non-IBD Control Cohort, Screening Cohort, Validation Cohort |
Primary outcome
Clinical Recurrence Rate at 6 Months
Time frame: 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.
Endoscopic Recurrence Rate at 6 Months
Time frame: 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.
5 secondary outcomes
Endoscopic Recurrence Rate at 1 Year
Time frame: 1 year after intestinal resection
Clinical Recurrence Rate at 1 Year
Time frame: 1 year after intestinal resection
Imaging Recurrence Rate at 1 Year
Time frame: 1 year after intestinal resection
Imaging Recurrence Rate at 6 Months
Time frame: 6 months after intestinal resection
Reoperation or Endoscopic Treatment Rate at 1 Year
Time frame: 1 year after intestinal resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease (CD) and Postoperative Recurrence and Metastasis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiang Gao, MD (+86-13502405878, gxiang@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Recurrence Rate at 6 Months (time frame: 6 months after intestinal resection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.