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

Integration of Subphenotypic Lesions, Imaging-Based Healing Outcomes, and Biomarker Trajectories in a Retrospective Analysis of a Single-Center Retrospective Crohn's Disease Cohort

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07644390

Enrollment

500

Registered

2026-06-12

Start date

2010-01-01

Completion date

2026-01-01

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Crohn's disease-related intestinal surgery	Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2026, whichever occurred first.	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.

Outcome results