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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174208
• Other study ID #: 2021-ZSLYEC-341
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: October 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Jiayin Yao, Professor
• Phone: 13826462890
• Email: yjyin[@]mail3.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 20, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Radiomics

Intervention

Other:
• CTE examination
each patients should have undergone CTE examination

Locations

Country	Name	City	State
China	the Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentages of surgery at one-year after diagnosis	percentages of surgery at one-year after diagnosis	2017-2021