Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies

Recruiting

• Conditions: Coeliac Disease

• Registration Number: NCT05786183
• Lead Sponsor: IRCCS Burlo Garofolo

Brief Summary

Intestinal Celiac Disease (CD)-antibodies have been described as the best marker to reveal progression toward villous atrophy and could become the diagnostic marker to make prompt diagnosis in the wide clinical spectrum of CD reducing the delay in diagnosis and treatment. The introduction of either anti-endomysial antibodies (EMA) assay or rapid anti-Transglutaminase 2 (TG2) test on supernatant of mechanically lysed biopsy samples in the clinical practice would improve the diagnosis of CD, especially in clinically challenging scenarios. The availability of an accurate test for identifying intestinal CD-antibodies that do not need the culture of intestinal biopsy is less expensive, less time consuming and easier to perform would facilitate the implementation of such technology outside research laboratories, and enable the diagnosis of CD at the end of Gastrointestinal Endoscopy (GIE).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-15
• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

• Patients undergoing an elective esophagogastroduodenoscopy (EGD) for suspected CD, eosinophilic esophagitis, autoimmune enteropathy, inflammatory bowel disease, gastritis, gastric or duodenal ulcer, gastroesophageal reflux disease.

Exclusion Criteria

• Bleeding disorders
• Patients fulfilling the new ESPGHAN Guidelines for diagnosing CD (version 2020), for a serology based CD diagnosis
• Subjects in whom intestinal biopsies are not indicated as part of the diagnostic process.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of EMA assay detected on supernatant of mechanically lysed intestinal biopsy specimens	At the time of endoscopic examination	Sensitivity and specificity of EMA assay detected on mechanically lysed intestinal biopsies compared to the reference standard (serology + histopathology)
Diagnostic accuracy of rapid anti-TG2 test detected on supernatant of mechanically lysed intestinal biopsy specimens	At the time of endoscopic examination	Sensitivity and specificity of rapid anti-TG2 test detected on mechanically lysed intestinal biopsies compared to the reference standard (serology + histopathology)

Secondary Outcome Measures

Name	Time	Method
Concordance of EMA assay and rapid anti-TG2 test on supernatant of mechanically lysed intestinal biopsy specimens with Culture-EMA results	At the time of endoscopic examination

Trial Locations

Locations (1)

IRCCS Burlo Garofolo; 🇮🇹 Trieste, Italy