Development of a Dynamic Prediction Model for Crohn's Disease-Related Intestinal Surgery Using Longitudinal Indices of Routine Blood Tests: A Single-Center Retrospective Cohort Study

NCT07644390 | Completed

• 1 other identifier: 2025ZSLYEC-512
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-center retrospective cohort study aims to develop and internally validate a dynamic prediction model that uses longitudinal data from routinely collected blood tests to continuously assess the risk of Crohn's disease (CD)-related intestinal surgery, and to construct a simplified tool for clinical application. Patients with a confirmed diagnosis of CD and serial routine blood tests available during long-term follow-up will be included. Longitudinal trajectories of laboratory markers will be characterized, and their association with CD-related intestinal surgery will be evaluated. A full-variable dynamic prediction model will be built using dynamic random survival forest methodology, and a parsimonious model incorporating only the core laboratory markers will be developed via Bayesian joint model. The goal is to establish a practical, non-invasive, and dynamic risk assessment framework to support the transition from reactive to proactive long-term management of CD.

Conditions

Crohn Disease (CD); Dynamic Prediction Model

Keywords

Crohn Disease (CD); dynamic prediction model; multivariate functional principal component analysis; Random survival forests; Bayesian joint models

Outcome Measures

Primary Outcomes (1)

• Crohn's disease-related intestinal surgery

  CD-related intestinal surgeries included intestinal resection, ostomy creation, and similar procedures. The onset of a CD-related intestinal surgery was defined as the time point when it was first detected on imaging during follow-up.

  Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2026, whichever occurred first.

Study Arms (1)

Retrospective Cohort of Patients with Crohn's Disease

Patients with a confirmed diagnosis of Crohn's disease (CD) were identified from a single-center electronic medical record database. Eligible patients were those who had at least three routine blood test records available during long-term follow-up and for whom complete information on baseline characteristics and CD-related intestinal surgery events could be ascertained. Serial longitudinal data of routine blood parameters were retrospectively extracted. The cohort will be used to develop and internally validate a dynamic prediction model for CD-related intestinal surgery.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This retrospective cohort study included patients with a confirmed diagnosis of Crohn's disease (CD) at the Inflammatory Bowel Disease Center of the Sixth Affiliated Hospital of Sun Yat-sen University between January 1, 2010, and December 31, 2019. All patients had regular follow-up at this center for more than 5 years and had at least two routine blood tests available during follow-up. Data were retrospectively collected from electronic medical records, with the last follow-up date of December 31, 2026.

You may qualify if:

• Confirmed diagnosis of CD
• Regular follow-up at this center for more than 5 years

You may not qualify if:

• Incomplete clinical data
• Fewer than 2 blood tests during the follow-up period

Sponsors & Collaborators

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

Related Publications (2)

• Ashton JJ, Satsangi J, Uhlig HH. Intestinal Inflammation and Extraintestinal Disease: Understanding Dynamic Risk. Gastroenterology. 2024 Jul;167(2):205-208. doi: 10.1053/j.gastro.2024.03.040. Epub 2024 Apr 10. No abstract available.

  PMID: 38604541 RESULT

• Zhou Q, Chen ZH, Peng S. Evaluating the application of dynamic prediction models in oncological prognostic studies with repeated measurement predictors. NPJ Precis Oncol. 2025 Nov 24;9(1):376. doi: 10.1038/s41698-025-01162-7.

  PMID: 41286498 RESULT

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: January 1, 2010
• Primary Completion: December 31, 2019
• Study Completion: January 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share