ICT Tools for the Diagnosis of Autoimmune Diseases

NACompletedINTERVENTIONAL
Enrollment

25,000

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

February 28, 2024

Study Completion Date

December 31, 2024

Conditions
Celiac Disease
Interventions
DIAGNOSTIC_TEST

PoCT+questionnaire administration

"In Sicily, screening will be carried out in the general practitioner's clinics (GPs). GPs will have to submit the patients attending their clinics to the PoCT + software tools questionnaire. Subjects who are PoCT positive and/or who reach the minimum score in the questionnaire will be considered 'patients at risk of CD' and must be subjected, with prior consent, to in-depth diagnostics using standard serological methods. The subjects resulting positive in the serological investigations will then undergo the appropriate endoscopic and biopsy investigations to ascertain the presence of CD. In Malta the recruitment will exactly repeat the modalities already carried out in the ITAMA project, through the schools of Malta (Maltese takers), while the laboratory and endoscopic examinations of the subjects who tested positive for the PoCT and/or who will reach the minimum score in the software tools questionnaire will be centralized at the Mater Dei hospital."

Trial Locations (2)

2090

Mater Dei Hospital, Valletta

90127

University Hospital of Palermo, Palermo

All Listed Sponsors
lead

University of Palermo

OTHER

NCT05715970 - ICT Tools for the Diagnosis of Autoimmune Diseases | Biotech Hunter | Biotech Hunter