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

August 1, 2025 updated by: Marta Molero, Instituto de Investigación Hospital Universitario La Paz

No-biopsy Approach for the Diagnosis of Celiac Disease: Definition of Cut-off Points for Different IgA Anti-tissue Transglutaminase Assays

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Sant Joan de Déu
        • Contact:
          • Elisabet Poyatos
      • Lugo, Spain
        • Recruiting
        • Hospital Universitario Lucus Augusti
        • Contact:
          • Julia María Cabo del Riego
      • Madrid, Spain, 28046
      • Madrid, Spain
        • Recruiting
        • Hospital Ramon y Cajal
        • Contact:
          • Garbiñe Roy Ariño
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
          • María José Martínez Becerra
    • Barcelona
      • Terrassa, Barcelona, Spain
        • Recruiting
        • Hospital Mutua Terrassa
        • Contact:
          • Albert Martin Cardona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-transglutaminase-IgA titer
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).
To define the optimal threshold for anti tTG-IgA levels using different commercially available assays that provide a positive predictive value of 100%.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborators

Hospital Universitario Ramon y Cajal
Hospital Universitario Fundación Jiménez Díaz
Hospital Sant Joan de Deu
Hospital Universitario Lucus Augusti
Hospital Universitari Mutua Terrassa
Instituto de Investigación Sanitaria Hospital Clínico San Carlos

Investigators

  • Principal Investigator: Marta Molero-Luis, Dr, Hospital Universitario La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-5473

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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