Status:
RECRUITING
No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsors:
Hospital Universitari Mutua Terrassa
Hospital Sant Joan de Deu
Conditions:
Celiac Disease
Eligibility:
All Genders
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 dis...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 2 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05983978
Start Date
January 2 2023
End Date
March 31 2026
Last Update
August 6 2025
Active Locations (6)
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1
Hospital Mutua Terrassa
Terrassa, Barcelona, Spain
2
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain
3
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
4
Hospital Sant Joan de Deu
Barcelona, Spain