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

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).

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Mutua Terrassa, Terrassa, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Anti-transglutaminase-IgA titer

Time frame: 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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Concepción Núñez Pardo de Vera, Dr

CONTACT

[email protected]

Marta Molero-Luis, Dr

CONTACT

[email protected]

0034660065755

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

Hospital Mutua de Terrassa
Hospital Sant Joan de Deu
Hospital Universitario Fundación Jiménez Díaz
Hospital Universitario Lucus Augusti
Hospital Universitario Ramon y Cajal
Instituto de Investigación Sanitaria Hospital Clínico San Carlos

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Aug 9, 2023
Registry last updated: Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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