Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies

NCT05786183 | Unknown

• 1 other identifier: RC 34/20
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

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).

Conditions

Coeliac Disease

Keywords

intestinal antibodies; Rapid test; Coeliac disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

• Age: 1 Year - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects included in the study will be children and young adults, between 1 to 22 years of age, referred to the Gastroenterology Unit for elective GIE

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Luigina De Leo

CONTACT

+39.040.3785.472; luigina.deleo@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 27, 2023
• Study Start: February 15, 2020
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

IT (1)