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RecruitingNCT05983978Updated Aug 6, 2025

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

An observational study in Celiac Disease, sponsored by Instituto de Investigación Hospital Universitario La Paz. Recruiting at 6 sites in Spain. Per ClinicalTrials.gov, last updated 2025-08-06.

Sponsored by Instituto de Investigación Hospital Universitario La Paz · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Sex
All
01

Study 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).

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Conditions studied

  • Celiac Disease

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Keywords

  • anti-transglutaminase IgA
  • no-biopsy approach
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In context

Celiac Disease

333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.

This study's planned enrollment of 150 is close to the median of 160 across 126 observational studies indexed under Celiac Disease.

Browse Celiac Disease studies →

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 100 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients will be consecutively recruited from the gastroenterology departments (either adult or pediatric) of the participating hospitals.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Anti-transglutaminase-IgA titer

    To define the optimal threshold for anti tTG-IgA levels using different commercially available assays that provide a positive predictive value of 100%.

    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).

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Study locations

6 of 6 sites recruiting
  • Hospital Mutua Terrassa
    Terrassa, Barcelona, Spain
    • Albert Martin Cardona · Contact
    Recruiting
  • Hospital Universitario Lucus Augusti
    Lugo, Lugo, Spain
    • Julia María Cabo del Riego · Contact
    Recruiting
  • Hospital Universitario La Paz
    Madrid, Madrid 28046, Spain
    Recruiting
  • Hospital Sant Joan de Deu
    Barcelona, Spain
    • Elisabet Poyatos · Contact
    Recruiting
  • Hospital Ramon y Cajal
    Madrid, Spain
    • Garbiñe Roy Ariño · Contact
    Recruiting
  • Hospital Universitario Fundación Jimenez Diaz
    Madrid, Spain
    • María José Martínez Becerra · Contact
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05983978
Lead sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Hospital Mutua de Terrassa, Hospital Sant Joan de Deu, Hospital Universitario Ramon y Cajal, Hospital Universitario Lucus Augusti, Hospital Universitario Fundación Jiménez Díaz, Instituto de Investigación Sanitaria Hospital Clínico San Carlos
Responsible party
Marta Molero (Doctor, Instituto de Investigación Hospital Universitario La Paz) — Principal investigator
First posted
Aug 9, 2023
Start date
Jan 2, 2023
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Aug 6, 2025

Study contacts

Marta Molero-Luis, Dr
Contact
marta.molero@salud.madrid.org
0034660065755
Concepción Núñez Pardo de Vera, Dr
Contact
conchita.npardo@gmail.com
Marta Molero-Luis, Dr
principal investigator · Hospital Universitario La Paz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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