Development and Validation of a Nomogram for Predicting Surgery in Newly-diagnosed Crohn's Disease: a Retrospective Cohort Study

June 12, 2024 updated by: Chao Li, First Affiliated Hospital, Sun Yat-Sen University
A majority of patients with Crohn's disease undergo surgery during the disease course. We aimed to develop an easily available nomogram to predict the risk of surgery at diagnosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Crohn's disease (CD), a chronic inflammatory disorder involving all of the gastrointestinal tract, has a progressive and destructive course and is increasing in incidence worldwide.1 Although the most common disease behavior of patients with newly-diagnosed CD is inflammatory (B1 in the Montreal Classification2), a rapid and prominent progression in disease behaviour will be observed in approximate half of the patients within 10 years after diagnosis.3-5 Data from a population-based cohort show that nearly half of patients developed intestinal complications such as strictures and fistulae, in the 20 years following the diagnosis.3 In spite of the application of immunosuppressive maintenance therapies, more than half of the patients suffer from severe complications and required intestinal resection.6,7 In recent decades, with the advent of targeted biologic therapies such as tumor necrosis factor antagonists, gut-selective monoclonal anti-integrin antibody and inhibitors of IL-12 and IL-23 signaling, the medical management of CD has been revolutionized.8 Earlier and more aggressive application of biologics or novel small molecules and combination therapies have been demonstrated to induce a profound alteration of natural disease course and diminish the requirement for hospitalization and surgery among patients with newly-diagnosed CD.9,10 Nevertheless, one of the most difficult challenges in the so-called top-down treatment strategy is the identification of patients who are at high risk for disease progression and thus necessitate more intensive treatment pattern despite the therapy-related adverse events and heavy costs. From another perspective, failure to identify high-risk patients also delays the prescription of more effective therapies and accounts for an increase in the risk of disease progression.

Much effort has been made in the field of baseline risk stratification for newly-diagnosed CD. Many clinical characteristics have been found to independently correlate with prognosis, including age at diagnosis, disease location, disease behavior, smoking status, and history of medication.9,11,12 Meanwhile, several prognostic biomarkers have been discovered in pilot studies, encompassing immune-related molecules and specific gene expression levels.13,14 Nonetheless, inconvenience and high expense has impeded their full validation and clinical application. Accordingly, the therapy selection is still tailored to the individual patient newly diagnosed with CD based on the clinical risk factors and patient comorbidities8, which is far from precision treatment.

In this era of artificial intelligence, a lot of machine learning models have been developed for innovation in all fields of inflammatory bowel disease, such as diagnosis, monitoring, disease course prediction and management.15 Unfortunately, the majority of popular machine learning prediction models are essentially black boxes, rendering verdicts with a few accompanying justifications, which limits clinical reliability and hence obstructs clinical implementation.16 To balance effectiveness with convenience and interpretability, we aimed to construct a well-interpreted Cox statistical regression model together with a nomogram based on clinical characteristics and available serological indicators to predict the long-term prognosis of newly diagnosed CD.

Study Type

Observational

Enrollment (Actual)

490

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients newly diagnosed with Crohn's disease

Description

Inclusion Criteria:

  • The diagnosis of CD was finally confirmed according to diagnostic criteria, including clinical manifestations and ileocolonoscopic, histopathologic, and radiologic evidence
  • Laboratory data of complete blood count and routine blood biochemical examination were available within one week before the diagnostic ileocolonoscopy

Exclusion Criteria:

  • The time of diagnosis was unclear
  • They underwent bowel resection within three months after diagnosis, which reflected an early complicated disease
  • They suffered from severe infection around the laboratory test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Requirement of surgery
Time Frame: Any time during the follow-up (up to Dec 31, 2022)
need for bowel resection at any time
Any time during the follow-up (up to Dec 31, 2022)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

June 8, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOMOGRAM for Nd-CD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Newly-diagnosed Crohn's Disease

Clinical Trials on immunosuppressant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe