A no-biopsy method for diagnosing celiac disease using antibody tests
No-biopsy Approach for the Diagnosis of Celiac Disease: Definition of Cut-off Points for Different IgA Anti-tissue Transglutaminase Assays
Instituto de Investigación Hospital Universitario La Paz · NCT05983978
This study is testing a new way to diagnose celiac disease using blood tests instead of needing a biopsy, and it's for both kids and adults who are newly diagnosed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | Instituto de Investigación Hospital Universitario La Paz (other) |
| Locations | 6 sites (Terrassa, Barcelona and 5 other locations) |
| Trial ID | NCT05983978 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to establish optimal thresholds for IgA anti-tissue transglutaminase (tTG-IgA) antibody assays to diagnose celiac disease without requiring an intestinal biopsy. It will evaluate the diagnostic performance of various commercially available assays and determine if a titer cut-off above 10 times the upper limit of normal is effective across all tests. The study will enroll both pediatric and adult patients with new-onset celiac disease during 2023 and 2024, collecting serum samples for analysis. The research seeks to improve diagnostic accuracy and patient experience by minimizing invasive procedures.
Who should consider this trial
Good fit: Ideal candidates include patients on a gluten-containing diet with elevated tTG-IgA antibodies and those meeting specific pediatric criteria without prior biopsy.
Not a fit: Patients already diagnosed with celiac disease or those who refuse a duodenal biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could simplify and enhance the diagnosis of celiac disease, reducing the need for invasive biopsies.
How similar studies have performed: While similar approaches have been explored, this study aims to refine and validate specific cut-off points for various assays, making it a novel contribution to the field.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Terrassa, Barcelona and 5 other locations
- Hospital Mutua Terrassa — Terrassa, Barcelona, Spain (RECRUITING)
- Hospital Universitario Lucus Augusti — Lugo, Lugo, Spain (RECRUITING)
- Hospital Universitario La Paz — Madrid, Madrid, 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)
Study contacts
- Principal investigator: Marta Molero-Luis, Dr — Hospital Universitario La Paz
- Study coordinator: Marta Molero-Luis, Dr
- Email: marta.molero@salud.madrid.org
- Phone: 0034660065755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Celiac Disease, anti-transglutaminase IgA, no-biopsy approach