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NCT05983978
No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays
trial in Celiac Disease in 150 participants. Currently enrolling.
31 March 2026
Quick facts
| Lead sponsor | Instituto de Investigación Hospital Universitario La Paz |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 2 January 2023 |
| Primary completion | 31 March 2026 |
| Estimated completion | 31 March 2026 |
| Sites | 6 locations across Spain |
Conditions studied
- Celiac Disease — all drugs for Celiac Disease →
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Who can join
Eligibility, any sex, with Celiac Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05983978
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Other Instituto de Investigación Hospital Universitario La Paz trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05983978 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto de Investigación Hospital Universitario La Paz
- Last refreshed: 6 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05983978.
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