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

Recruiting now

Conditions studied: Celiac Disease

In brief

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).

Key facts

Study ID: NCT05983978
Run by: Instituto de Investigación Hospital Universitario La Paz
People needed: 150
Starts: 2023-01-02
Expected to finish: 2026-03-31
Last updated by the study team: 2025-08-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients, on gluten-containing diet, with TGt-IgA antibodies > Upper Limit of Normal (ULN) and intestinal biopsy confirming celiac disease (CD).
Patients with TCRγδ+ >10% combined with decrease NK-like intraepithelial lymphocytes in the intestinal epithelium.
Paediatric patients who meet ESPGHAN criteria (TGt-IgA antibodies >10xULN) without duodenal biopsy performed.

You may not qualify if…

Patients already diagnosed with CD.
Patients who refused duodenal biopsy.
Patients with primary or secondary immunodeficiencies.
Patients with malignancy.
Recruited patients whose remaining serum cannot be sent to the reference centre, whose biopsies are of poor quality or who nod not sign the informed consent from.

Where it is running

Hospital Mutua Terrassa — Terrassa, Barcelona, Spain (enrolling)
Hospital Universitario Lucus Augusti — Lugo, Lugo, Spain (enrolling)
Hospital Universitario La Paz — Madrid, Madrid, Spain (enrolling)
Hospital Sant Joan de Deu — Barcelona, Spain (enrolling)
Hospital Ramon y Cajal — Madrid, Spain (enrolling)
Hospital Universitario Fundación Jimenez Diaz — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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