RecruitingNCT05983978

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

No-biopsy Approach for the Diagnosis of Celiac Disease: Definition of Cut-off Points for Different IgA Anti-tissue Transglutaminase Assays


Sponsor

Instituto de Investigación Hospital Universitario La Paz

Enrollment

150 participants

Start Date

Jan 2, 2023

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with celiac disease. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(6)

Hospital Mutua Terrassa

Terrassa, Barcelona, Spain

Hospital Universitario Lucus Augusti

Lugo, Lugo, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Sant Joan de Deu

Barcelona, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hospital Universitario Fundación Jimenez Diaz

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05983978


Related Trials