The Innate Immune Response and Enteric Nervous System in Crohn's Disease.

NCT06485193 | Terminated

• 1 other identifier: N-20230024
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to explore the relationships between inflammation, nerve changes, and the expression of interferon-stimulated proteins in inflamed and non-inflamed bowel areas from patients with Crohn's disease. Crohn's disease is a chronic inflammatory condition with complex causes and mechanisms that remain uncertain despite extensive research. Methods and Procedures This exploratory study utilizes tissue samples from a clinical biobank at Aalborg University Hospital. The samples are paraffin-embedded blocks from which tissue sections are prepared for immunohistochemical and histological staining. The study focuses on assessing the expression of interferon-stimulated proteins through optimized immunohistochemical staining methods, ensuring reproducibility via automated machines. The protein expressions are then analyzed qualitatively and semi-quantitatively and compared with structural changes in the bowel tissues.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• MxA expression

  Immunohistochemical Mxa expression

  June 1 2024

Secondary Outcomes (1)

• Enterovirus positivity

  June 1 2024

Interventions

Immunohistochemistry DIAGNOSTIC_TEST

Immunohistochemical analysis of archived diagnostic tissue samples.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn's disease

You may qualify if:

• Histological preparations (tissue samples) from patients with Crohn's disease who have undergone bowel resection at Aalborg University Hospital in the period from 2012 to 2023.

You may not qualify if:

• If the tissue material does not include the ileocecal region.
• If the pathology report does not indicate that there is tissue material from both inflamed and non-inflamed areas.
• If the patient has registered a prohibition against research in the Tissue Utilization Registry.
• The selection of cases starts with the most recent (by date) and stops when 25 suitable cases are found.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, Northern Region, 9000, Denmark

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: September 4, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)