No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays
NCT ID: NCT05983978
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2023-01-02
2026-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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.
ALL
No
Sponsors
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Hospital Universitari Mutua Terrassa
UNKNOWN
Hospital Sant Joan de Deu
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital Universitario Lucus Augusti
OTHER
Hospital Universitario Fundación Jiménez Díaz
OTHER
Instituto de Investigación Sanitaria Hospital Clínico San Carlos
UNKNOWN
Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Marta Molero
Doctor
Principal Investigators
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Marta Molero-Luis, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Paz
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Albert Martin Cardona
Role: primary
Julia María Cabo del Riego
Role: primary
Elisabet Poyatos
Role: primary
Garbiñe Roy Ariño
Role: primary
María José Martínez Becerra
Role: primary
Other Identifiers
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PI-5473
Identifier Type: -
Identifier Source: org_study_id
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