No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays

Recruiting

• Conditions: Celiac Disease

• Registration Number: NCT05983978
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

The main objective of this multicenter and observational study is to define the optimal threshold of different commercially available IgA anti-transglutaminase (tTG-IgA) antibody assays for celiac disease diagnosis (CD) avoiding the need for an intestinal biopsy.

The main questions to be answered are:

* Is the anti-tTG-IgA titer cut-off above 10 times the upper limit of normal (ULN) useful in all anti-tTG IgA assays?

* Is the diagnostic performance of the newly defined cut-offs of anti-tTG-IgA the same in all the evaluated assays?

* Is the dynamic of the anti-tTG-IgA levels after the introduction of the gluten-free diet (GFD) similar across the different assays included in the study?

This is a prospective multicenter study that will enroll pediatric and adult patients with new-onset CD during the years 2023 and 2024. Serum from these patients will be collected for the determination of anti-tTG-IgA according to the local methodology (participating hospital) and by the anti-tTG IgA assays most commonly used in our country, which will be centralized in the same reference center (Hospital Universitario La Paz).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-02
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-transglutaminase-IgA titer	The tTG-IgA will be measured at the time of patient recruitment and at the first follow-up (3-6 months from the start of the gluten-free diet).	To define the optimal threshold for anti tTG-IgA levels using different commercially available assays that provide a positive predictive value of 100%.

Trial Locations

Locations (6)

Hospital Mutua Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Sant Joan de Deu; 🇪🇸 Barcelona, Spain

Hospital Universitario Lucus Augusti; 🇪🇸 Lugo, Spain

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Fundación Jimenez Diaz; 🇪🇸 Madrid, Spain