Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05786183

Enrollment

163

Registered

2023-03-27

Start date

2020-02-15

Completion date

2024-03-15

Last updated

2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coeliac Disease

Keywords

intestinal antibodies, Rapid test, Coeliac disease

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).

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Years to 22 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	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

Countries

Italy

Contacts

Primary ContactLuigina De Leo

luigina.deleo@burlo.trieste.it+39.040.3785.472

Outcome results