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

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05174208
• Collaborator: (none)
• Enrollment: 300
• Anticipated Duration (Months): 11.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease; Prognostic Model; Radiomics	Other: CTE examination

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Study of Imaginomics Predicting Early Surgical Rates in Crohn's Disease
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Sep 20, 2022
• Anticipated Study Completion Date: Dec 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
CD	Other: CTE examination; each patients should have undergone CTE examination

Outcome Measures

Primary Outcome Measures

1. percentages of surgery at one-year after diagnosis [2017-2021]

   percentages of surgery at one-year after diagnosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT05174208
• Other Study ID Numbers: 2021-ZSLYEC-341
• First Posted: Dec 30, 2021
• Last Update Posted: Dec 30, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Crohn Disease

Study Results

No Results Posted as of Dec 30, 2021