NCT05983978

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

3.2 years

First QC Date

July 31, 2023

Last Update Submit

August 1, 2025

Conditions

Celiac Disease

Keywords

anti-transglutaminase IgAno-biopsy approach

Outcome Measures

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%.

    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).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Mutua Terrassa

Terrassa, Barcelona, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Lugo, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital Sant Joan de Deu

Barcelona, Spain

RECRUITING

Hospital Ramon y Cajal

Madrid, Spain

RECRUITING

Hospital Universitario Fundación Jimenez Diaz

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Marta Molero-Luis, Dr

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Molero-Luis, Dr

CONTACT

0034660065755marta.molero@salud.madrid.org

Concepción Núñez Pardo de Vera, Dr

CONTACT

conchita.npardo@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 9, 2023

Study Start

January 2, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations

ES(6)