Clinical trial NCT05983978: No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays
Official title: No-biopsy Approach for the Diagnosis of Celiac Disease: Definition of Cut-off Points for Different IgA Anti-tissue Transglutaminase Assays
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Celiac Disease
Keywords: anti-transglutaminase IgA
no-biopsy approach
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Mutua Terrassa
name: Hospital Sant Joan de Deu
name: Hospital Universitario Ramon y Cajal
name: Hospital Universitario Lucus Augusti
name: Hospital Universitario Fundación Jiménez Díaz
name: Instituto de Investigación Sanitaria Hospital Clínico San Carlos
First posted: 2023-08-09
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be consecutively recruited from the gastroenterology departments (either adult or pediatric) of the participating hospitals.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Anti-transglutaminase-IgA titer
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Mutua Terrassa
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jimenez Diaz
Study officials:
affiliation: Hospital Universitario La Paz
name: Marta Molero-Luis, Dr
role: PRINCIPAL_INVESTIGATOR
References: