Role of IL 12 and IL 23 as Potential Biomarkers in Diagnosis of Early Crohn's Disease

NCT06844565 | Completed

• 1 other identifier: 36264PR1059/1/25
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the role of Interleukin (IL)-12 and IL-23 as potential biomarkers in the diagnosis of early Crohn's disease.

Conditions

Interleukin 12; Interleukin 23; Biomarker; Diagnosis; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity of IL-23 to predict Crohn's disease

  Sensitivity of IL-23 to predict Crohn's disease will be recorded.

  6 months after procedure

Secondary Outcomes (1)

• Sensitivity of IL-12 to predict Crohn's disease

  6 months after procedure

Study Arms (1)

Study group

Patients who are suspected of having Crohn's disease clinically and by colonoscopy (like ulcers, fistulas, or skip lesions). Non-specific ileitis by histopathology.

Procedure: Immunohistochemistry procedure

Interventions

Immunohistochemistry procedure PROCEDURE

Briefly, all slides will be rehydrated, and antigen retrieval will be performed using sodium citrate (pH = 6.0) in a pressure cooker (EDTA buffer, pH = 8.4). All slides will be blocked with endogenous peroxidase with 3% hydrogen peroxide and blocked non-specific protein with 2.5% bovine serum albumin in phosphate-buffered saline. If the result shows non-specific ileitis, immunohistochemical staining for IL-12 and IL-23 will be performed using sandwich enzyme-linked immunosorbent assays (ELISA).

Study group

Eligibility Criteria

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

Study Population

This retrospective study will be carried out on 110 patients suspected of having Crohn's disease are present in Tanta University Hospitals in the period from January 2021 to December 2023 and the data will be collected in the duration from February 2025 to May 2025 that after approval from the institutional ethical committee.

You may qualify if:

• Age from 18 to 65 years.
• Both sexes.
• Patients who are suspected of having Crohn's disease clinically and by colonoscopy (like ulcers, fistulas, or skip lesions).
• Non-specific ileitis by histopathology.

You may not qualify if:

• Patients with no pathological samples through colonoscopy.
• History of other significant gastrointestinal diseases (e.g., colon cancer, ischemic bowel disease).
• Immunosuppressive therapy or biologic agents at the time of study.
• Previous abdominal surgeries.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Disease; Crohn Disease

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Internal Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)