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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

8. juni 2026 opdateret af: Sixth Affiliated Hospital, Sun Yat-sen University

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

500

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Crohn's disease-related intestinal surgery
Tidsramme: 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.
Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2026, whichever occurred first.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2010

Primær færdiggørelse (Faktiske)

31. december 2019

Studieafslutning (Faktiske)

1. januar 2026

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025ZSLYEC-512

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Crohns sygdom (CD)

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