Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease

RecruitingOBSERVATIONAL
Enrollment

332

Participants

Timeline

Start Date

October 4, 2023

Primary Completion Date

May 31, 2025

Study Completion Date

May 31, 2025

Conditions
Celiac Disease in Children
Interventions
DIAGNOSTIC_TEST

Diagnostic Test: Rapid Intestinal anti-TG2 Assay

"Evaluation of the reliability of the Rapid Intestinal anti-TG2 Assay for revealing anti-TG2 antibodies in duodenal biopsy specimens of patients suffering from CD, especially potential CD in which the diagnosis may be challenging.~Intestinal anti-TG2 will be investigated also in patients suffering from other non-CD related gastrointestinal disorders. Sensitivity, specificity and likelihood ratios of the Rapid Intestinal anti-TG2 assay will be calculated and compared to the reference standard (serology + histopathology) of CD diagnosis."

DIAGNOSTIC_TEST

Diagnostic Test: Rapid Intestinal anti-TG2 Assay

"Evaluation of the reliability of the Rapid Intestinal anti-TG2 Assay for revealing anti-TG2 antibodies in duodenal biopsy specimens of patients suffering from CD, especially potential CD in which the diagnosis may be challenging.~Intestinal anti-TG2 will be investigated also in patients suffering from other non-CD related gastrointestinal disorders. Sensitivity, specificity and likelihood ratios of the Rapid Intestinal anti-TG2 assay will be calculated and compared to the reference standard (serology + histopathology) of CD diagnosis."

Trial Locations (4)

34137

RECRUITING

"Institute for Maternal and Child Health - IRCCS Burlo Garofolo", Trieste

Unknown

RECRUITING

Azienda Ospedaliera Universitaria Federico II, Napoli

ACTIVE_NOT_RECRUITING

Consorzio per Valutazioni Biologiche e Faramacologiche, Pavia

RECRUITING

Azienda ULSS2 Marca Trevigiana, Treviso

All Listed Sponsors
lead

IRCCS Burlo Garofolo

OTHER