NCT05983978 No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays
| NCT ID | NCT05983978 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Hospital Universitario La Paz |
| Condition | Celiac Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-01-02 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-01-02 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Marta Molero-Luis, Dr
PRINCIPAL INVESTIGATOR
Hospital Universitario La Paz
Frequently Asked Questions
Who can join the NCT05983978 clinical trial?
This trial is open to participants of all sexes, studying Celiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05983978 currently recruiting?
Yes, NCT05983978 is actively recruiting participants. Contact the research team at marta.molero@salud.madrid.org for enrollment information.
Where is the NCT05983978 trial being conducted?
This trial is being conducted at Terrassa, Spain, Lugo, Spain, Madrid, Spain, Barcelona, Spain and 2 additional locations.
Who is sponsoring the NCT05983978 clinical trial?
NCT05983978 is sponsored by Instituto de Investigación Hospital Universitario La Paz. The principal investigator is Marta Molero-Luis, Dr at Hospital Universitario La Paz. The trial plans to enroll 150 participants.