Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies

Coeliac Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786183
• Other study ID #: RC 34/20
• Status: Recruiting
• Start date: February 15, 2020
• Est. completion date: March 15, 2024

Study information

• Verified date: March 2023
• Source: IRCCS Burlo Garofolo
• Contact: Luigina De Leo
• Phone: +39.040.3785.472
• Email: luigina.deleo[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 163
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease
• Coeliac Disease

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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