Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies

Sponsor

IRCCS Burlo Garofolo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05786183

Collaborator

(none)

163

Enrollment

Location

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coeliac Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

163 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

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

Actual Study Start Date :

Feb 15, 2020

Anticipated Primary Completion Date :

Mar 15, 2024

Anticipated Study Completion Date :

Mar 15, 2024

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Burlo Garofolo	Trieste		Italy	34137

Sponsors and Collaborators

IRCCS Burlo Garofolo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IRCCS Burlo Garofolo

ClinicalTrials.gov Identifier:

NCT05786183

Other Study ID Numbers:

RC 34/20

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by IRCCS Burlo Garofolo

intestinal antibodies

Rapid test

Coeliac disease

Additional relevant MeSH terms:

Celiac Disease

Study Results

No Results Posted as of Mar 27, 2023