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OpenTrials
Completed

NCT Number: NCT07644390

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Crohn's disease-related intestinal surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2019
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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