NCT05174208

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

September 24, 2021

Last Update Submit

April 23, 2026

Conditions

Crohn DiseasePrognostic ModelRadiomics

Outcome Measures

Primary Outcomes (1)

  • percentages of surgery at one-year after diagnosis

    percentages of surgery at one-year after diagnosis

    2017-2021

Study Arms (1)

CD

Other: CTE examination

Interventions

CTE examinationOTHER

each patients should have undergone CTE examination

CD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 501655, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2021

First Posted

December 30, 2021

Study Start

January 1, 2022

Primary Completion

September 20, 2024

Study Completion

December 20, 2024

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

CN(1)