ICT Tools for the Diagnosis of Autoimmune Diseases (ITAMA_CAP)
Celiac Disease
About this trial
This is an interventional screening trial for Celiac Disease focused on measuring Celiac Disease, Point-of-Care-Test, Diagnosis
Eligibility Criteria
Inclusion Criteria: age >12 and <18 years for subjects enrolled in Malta; age >18 years for subjects enrolled in Sicily. Exclusion Criteria: age <12 and >18 years for subjects enrolled in Malta; age <18 years for subjects enrolled in Sicily; refusal to undergo the proposed diagnostic procedures; lack of informed consent.
Sites / Locations
- University Hospital of Palermo
- Mater Dei Hospital
Arms of the Study
Arm 1
Experimental
General population
25,000 subjects, divided between Sicily and Malta. Approximately 10,000 students aged between 12 and 18 will be enrolled in Malta and approximately 15,000 adults (>18 years) will be enrolled in Sicily. These numbers are dictated by the need to obtain heterogeneous samples comparable with the subjects diagnosed in the previous ITAMA project (20,000). In Sicily, screening will be carried out in the GPs (Italian takers) clinics. In Malta the recruitment will be performed in the schools (Maltese takers). Furthermore, in Malta, a further extension of the results provides for the execution of the PoCT+questionnaire in the asymptomatic first-degree relatives of the pediatric subjects with an ascertained diagnosis of CD identified in the previous project.