Neurophenotype Predicts CD Disease Progression

NCT06452550 | Recruiting

• 1 other identifier: 82070680
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is aimed to develop a novel multimodal neuroimaging-based model to characterize the neurophenotype of Crohn's Disease patients and assess its ability for predicting disease progression, using multiomics data to interpret the model. Participants will be followed-up of at least six months for patients without disease progression to assess the relationship between neurophenotype and intestinal outcomes.

Conditions

Radiomics; Multi-omics

Keywords

Abdominal MRI; Magnetic Resonance Imaging; Crohn's disease; Brain/gut interaction

Outcome Measures

Primary Outcomes (1)

• The area under the ROC curve (AUC) to assess the performance of diagnostic model

  After baseline brain MRI scanning, patients were followed up.

  6 months

Study Arms (2)

Crohn's disease patients with no-to-mild inflammation

On MR enterography, the Magnetic Resonance Index of Activity (MaRIA) and Magnetic Resonance Enterography Global Score (MEGS) were used to characterize intestinal inflammation by assessing intramural and extramural lesions in both the small and large intestines. In ileocolonoscopy, the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) was used to quantify mucosal or luminal lesions from the terminal ileum to the colorectum. Both modalities were used to classify patients with no-to-mild or moderate-to-severe inflammation. We defined patients as having moderate-to-severe inflammation when at least two of the following criteria were met: (1) MaRIA≥11; (2) MEGS≥ 10 for the small bowel or MEGS≥12 for the colon; or (3) SES-CD≥11. Otherwise, patients were categorized as having no-to-mild inflammation.

Diagnostic Test: Logistic regression (LR) prediction models

Crohn's disease patients with moderate-to-severe inflammation

On MR enterography, the Magnetic Resonance Index of Activity (MaRIA) and Magnetic Resonance Enterography Global Score (MEGS) were used to characterize intestinal inflammation by assessing intramural and extramural lesions in both the small and large intestines. In ileocolonoscopy, the Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) was used to quantify mucosal or luminal lesions from the terminal ileum to the colorectum. Both modalities were used to classify patients with no-to-mild or moderate-to-severe inflammation. We defined patients as having moderate-to-severe inflammation when at least two of the following criteria were met: (1) MaRIA≥11; (2) MEGS≥ 10 for the small bowel or MEGS≥12 for the colon; or (3) SES-CD≥11. Otherwise, patients were categorized as having no-to-mild inflammation.

Diagnostic Test: Logistic regression (LR) prediction models

Interventions

Logistic regression (LR) prediction models DIAGNOSTIC_TEST

Logistic regression model was used to establish a model to distinguish different levels of intestinal inflammation.

Crohn's disease patients with moderate-to-severe inflammation; Crohn's disease patients with no-to-mild inflammation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study included adult patients aged 18 to 45 with Crohn's disease (CD) who were admitted to the First Affiliated Hospital of Sun Yat-sen University between May 2021 and June 2025.

You may qualify if:

• (a) CD patients aged 18-45 years; (b) the completion of multimodal brain MRI and administration of psychological questionnaires; (c) MR enterography (MRE), ileocolonoscopy, and blood or faecal samples, collection within one week of brain MRI; (d) a follow-up of at least six months for patients without disease progression; and (e) right-handedness.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

XploreMET v3.0 system

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Xuehua Li

  Sun Yat-sen University First Affiliated Hospital Department of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuehua Li

CONTACT

13580364103; lxueh@mail.sysu.edu.cn

Ruonan Zhang

CONTACT

15124748450; zhangrn25@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: May 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

CN (1)