Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease

Celiac Disease in Children Clinical Trial

Official title:

Validation of a New Innovative Method for the Easy Detection of a Disease Specific Marker to Make Prompt Diagnosis of Celiac Disease in All the Clinical Manifestations: a Paediatric Multicenter Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324539
• Other study ID #: PNRR-POC-2022-12376280
• Status: Recruiting
• Start date: October 4, 2023
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: IRCCS Burlo Garofolo
• Contact: Alberto Tommasini, MD PhD Prof
• Phone: +39.040.3785.422
• Email: alberto.tommasini[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Celiac disease (CD) is a common auto-immune disorder induced by gluten ingestion in genetically susceptible individuals (HLA-DQ2/DQ8). Gluten induces small-bowel villous atrophy and a specific immune response characterized by the production of CD-autoantibodies against transglutaminase 2 (anti-TG2) and endomysium (EMA). In symptomatic patients with positive-serum antibodies and villous atrophy, the diagnosis of CD is clearcut.

However, 10-30% of patients evaluated for suspected CD show only mild histopathologic changes and fluctuating serologic markers, a condition identified as potential CD. In such cases the diagnosis may remain uncertain.

CD-autoantibodies are produced by intestinal B-cells in the early phases of the disease, before their appearance in the serum and when the duodenal mucosa is still normal. Intestinal CD-antibodies (I-CD-abs) are a marker of CD, have a high sensitivity and specificity for CD and identify those patients with potential CD who are at risk of progression to villous atrophy. I-CD-abs can be detected by double immunofluorescence staining on frozen duodenal sections or by using an endomysial antibody assay in the culture medium of duodenal biopsies (EMAbiopsy).

The diagnostic accuracy of these techniques is comparable as they both have high sensitivity and specificity. However, their implementation in clinical practice is limited because they require both experienced operators and well-equipped laboratories. There is an unmet need: the development of a new simple and effective diagnostic tool that any gastroenterology unit can use in routine diagnostics to ensure a prompt diagnosis in suspected CD patients, who may benefit from a therapy based on gluten-free diet, and to reduce both unnecessary medical investigations and diagnostic delays.

In order to simplify and shorten times for the detection of these intestinal antibodies, the study aims to substitute the EMAbiopsy assay with a supernatant obtained quickly after mechanical lysis of fresh intestinal biopsy specimen. The obtained samples will be tested with rapid (about 15 minutes) immune-chromatographic anti-TG2 assay (Rapid Intestinal anti-TG2 Assay).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 332
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Bleeding disorders

• Patients fulfilling the new European Society for Paediatric Gastroenterology Hepatology and Nutrition (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
• Celiac Disease in Children

Intervention

Diagnostic Test:
• Diagnostic Test: Rapid Intestinal anti-TG2 Assay
Evaluation of the reliability of the Rapid Intestinal anti-TG2 Assay for revealing anti-TG2 antibodies in duodenal biopsy specimens of patients suffering from CD, especially potential CD in which the diagnosis may be challenging. Intestinal anti-TG2 will be investigated also in patients suffering from other non-CD related gastrointestinal disorders. Sensitivity, specificity and likelihood ratios of the Rapid Intestinal anti-TG2 assay will be calculated and compared to the reference standard (serology + histopathology) of CD diagnosis.
• Diagnostic Test: Rapid Intestinal anti-TG2 Assay
Evaluation of the reliability of the Rapid Intestinal anti-TG2 Assay for revealing anti-TG2 antibodies in duodenal biopsy specimens of patients suffering from CD, especially potential CD in which the diagnosis may be challenging. Intestinal anti-TG2 will be investigated also in patients suffering from other non-CD related gastrointestinal disorders. Sensitivity, specificity and likelihood ratios of the Rapid Intestinal anti-TG2 assay will be calculated and compared to the reference standard (serology + histopathology) of CD diagnosis.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Consorzio per Valutazioni Biologiche e Faramacologiche	Pavia
Italy	Azienda ULSS2 Marca Trevigiana	Treviso
Italy	Institute for Maternal and Child Health - 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	Sensitivity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis		Through study completion, an average of 18 months
Primary	Specificity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis		Through study completion, an average of 18 months
Primary	Sensitivity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis		Through study completion, an average of 18 months
Primary	Specificity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis		Through study completion, an average of 18 months