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

NCT05983978 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-08-06

No results posted yet for this 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).

Conditions

Sponsors & Collaborators

  • Hospital Universitari Mutua Terrassa

    collaborator UNKNOWN

  • Hospital Sant Joan de Deu

    collaborator OTHER

  • Hospital Universitario Ramon y Cajal

    collaborator OTHER

  • Hospital Universitario Lucus Augusti

    collaborator OTHER

  • Hospital Universitario Fundación Jiménez Díaz

    collaborator OTHER

  • Instituto de Investigación Sanitaria Hospital Clínico San Carlos

    collaborator UNKNOWN

  • Instituto de Investigación Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Marta Molero-Luis, Dr · Hospital Universitario La Paz

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05983978 on ClinicalTrials.gov