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

Sponsor
Instituto de Investigación Hospital Universitario La Paz (Other)
Overall Status
Recruiting
CT.gov ID
NCT05983978
Collaborator
Hospital Universitari Mutua Terrassa (Other), Hospital Sant Joan de Deu (Other), Hospital Universitario Ramon y Cajal (Other), Hospital Universitario Lucus Augusti (Other), Hospital Universitario Fundación Jiménez Díaz (Other), Instituto de Investigación Sanitaria Hospital Clínico San Carlos (Other)
150
Enrollment
6
Locations
16.9
Anticipated Duration (Months)
25
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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 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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    No-biopsy Approach for the Diagnosis of Celiac Disease: Definition of Cut-off Points for Different IgA Anti-tissue Transglutaminase Assays
    Actual Study Start Date :
    Jan 2, 2023
    Anticipated Primary Completion Date :
    Oct 31, 2023
    Anticipated Study Completion Date :
    May 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Anti-transglutaminase-IgA titer [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%.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Mutua Terrassa Terrassa Barcelona Spain
    2 Hospital Sant Joan de Deu Barcelona Spain
    3 Hospital Universitario Lucus Augusti Lugo Spain
    4 Hospital Universitario La Paz Madrid Spain 28046
    5 Hospital Ramon y Cajal Madrid Spain
    6 Hospital Universitario Fundación Jimenez Diaz Madrid Spain

    Sponsors and Collaborators

    • Instituto de Investigación Hospital Universitario La Paz
    • Hospital Universitari Mutua 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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marta Molero, Doctor, Instituto de Investigación Hospital Universitario La Paz
    ClinicalTrials.gov Identifier:
    NCT05983978
    Other Study ID Numbers:
    • PI-5473
    First Posted:
    Aug 9, 2023
    Last Update Posted:
    Aug 14, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marta Molero, Doctor, Instituto de Investigación Hospital Universitario La Paz
    anti-transglutaminase IgA
    no-biopsy approach
    Additional relevant MeSH terms:
    Celiac Disease

    Study Results

    No Results Posted as of Aug 14, 2023