Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies

Study Overview
=================
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).

Official Title
-----------------
Diagnostic Accuracy of a Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies to Enable a Real Time Diagnosis of Celiac Disease

Conditions
-----------------
Coeliac Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intestinal antibodies, Rapid test, Coeliac disease