CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 500 enrolled / 500 target
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07644390
NCT07644390N/ACompletedMonitor (2.5/mo)Completion was 78mo ago
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Integration of Subphenotypic Lesions, Imaging-Based Healing Outcomes, and Biomarker Trajectories in a Retrospective Analysis of a Single-Center Retrospective Crohn's Disease Cohort

Sixth Affiliated Hospital, Sun Yat-sen University·observational·Posted Jun 12, 2026·Updated Jun 12, 2026

In Brief

An observational study for Crohn Disease (CD) and Dynamic Prediction Model. Completed, enrolled 500 participants.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease (CD), Dynamic Prediction Model
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 12, 2026
Enrollment StartJan 1, 2010
Primary CompletionDec 31, 2019
Study CompletionJan 1, 2026
TodayJul 2, 2026
Enrollment to primary: 10 yearsPosted 20 days ago

Arms & Interventions

Retrospective Cohort of Patients with Crohn's Diseaseother

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.