Actively Recruiting
No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays
Led by Instituto de Investigación Hospital Universitario La Paz · Updated on 2025-08-06
150
Participants Needed
6
Research Sites
169 weeks
Total Duration
On this page
Sponsors
I
Instituto de Investigación Hospital Universitario La Paz
Lead Sponsor
H
Hospital Mutua de Terrassa
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients on a gluten-containing diet with tTG-IgA antibodies above the upper limit of normal and intestinal biopsy confirming celiac disease
- Patients with TCRb3b4+ greater than 10% combined with decreased NK-like intraepithelial lymphocytes in the intestinal epithelium
- Pediatric patients meeting ESPGHAN criteria with tTG-IgA antibodies more than 10 times the upper limit of normal without duodenal biopsy
You will not qualify if you...
- Patients previously diagnosed with celiac disease
- Patients who refused duodenal biopsy
- Patients with primary or secondary immunodeficiencies
- Patients with malignancy
- Patients whose serum cannot be sent to the reference center, whose biopsies are poor quality, or who did not sign informed consent
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Hospital Mutua Terrassa
Terrassa, Barcelona, Spain
Actively Recruiting
2
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain
Actively Recruiting
3
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Actively Recruiting
4
Hospital Sant Joan de Deu
Barcelona, Spain
Actively Recruiting
5
Hospital Ramon y Cajal
Madrid, Spain
Actively Recruiting
6
Hospital Universitario Fundación Jimenez Diaz
Madrid, Spain
Actively Recruiting
Research Team
M
Marta Molero-Luis, Dr
CONTACT
C
Concepción Núñez Pardo de Vera, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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