Study of Imaginomics Predicting Early Surgical Rates in Crohn's Disease

December 3, 2023 updated by: Sixth Affiliated Hospital, Sun Yat-sen University
Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. Most CD patients require surgery for complications, including stenosis, perforation, and severe intestinal bleeding. Predicting early-onset surgery risk is of great importance to assist launching of therapeutic strategies. We aim to establish a digital prognostic model and nomogram using radiomics, which will help clinical practice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 501655
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-Sen University
        • Contact:

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

2017-2020 CD patients in the IBD center of Sixth Affiliated Hospital of Sun Yat-Sen University.

Description

Inclusion Criteria:

patients with a confirmed diagnosis of CD; a follow-up more than 1 year; without previous CD-associated intestinal surgeries; complete data of CTE.

Exclusion Criteria:

patients without a confirmed diagnosis of CD; with incomplete data and a follow-up less than 1 year; patients have previous intestinal surgeries; patients who have never undergone CTE examination.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CD
Other: CTE examination
each patients should have undergone CTE examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentages of surgery at one-year after diagnosis
Time Frame: 2017-2021
percentages of surgery at one-year after diagnosis
2017-2021

Collaborators and Investigators

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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

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, 2022

Primary Completion (Estimated)

September 20, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

September 24, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

December 30, 2021

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-ZSLYEC-341

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.

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