Integration of Subphenotypic Lesions, Imaging-Based Healing Outcomes, and Biomarker Trajectories in a Retrospective Analysis of a Single-Center Retrospective Crohn's Disease Cohort
Sponsor study identifier
observational
500
0 countries
N/A
Study Start
January 1, 2010
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
January 1, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2010
Actual (reported)December 31, 2019
Actual (reported)January 1, 2026
Actual (reported)June 8, 2026
Actual (reported)June 12, 2026
Actual (reported)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.
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.
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.
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.
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.
500 participants (actual enrollment reported by the registry).
First Submitted
June 8, 2026
First Posted
June 12, 2026
Study Start
January 1, 2010
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 31, 2019
Actual (reported)Study Completion
January 1, 2026
Actual (reported)Last Updated
June 12, 2026
Record last verified: 2026-06
The individual participant data were collected retrospectively from routine clinical practice without specific informed consent for data sharing. Institutional ethics approval does not permit public deposition of patient-level data.
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Source: ClinicalTrials.gov.
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