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

Celiac Disease Clinical Trial

Official title:

No-biopsy Approach for the Diagnosis of Celiac Disease: Definition of Cut-off Points for Different IgA Anti-tissue Transglutaminase Assays

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05983978
• Other study ID #: PI-5473
• Status: Recruiting
• Start date: January 2, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Marta Molero-Luis, Dr
• Phone: 0034660065755
• Email: marta.molero[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 TCR?d+ >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.

Related Conditions & MeSH terms

• Celiac Disease

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Deu	Barcelona
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario Fundación Jimenez Diaz	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Mutua Terrassa	Terrassa	Barcelona

Sponsors (7)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Hospital Sant Joan de Deu, Hospital Universitari Mutua Terrassa, Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario Lucus Augusti, Hospital Universitario Ramon y Cajal, Instituto de Investigación Sanitaria Hospital Clínico San Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).