ICT Tools for the Diagnosis of Autoimmune Diseases in the Mediterranean Area_CAPITALISATION PROJECT
Trial ID: NCT05715970
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-06-01
Completion date: 2024-12-31
Sponsor: University of Palermo
Conditions: Celiac Disease
Interventions: PoCT+questionnaire administration
Locations: University Hospital of Palermo; Mater Dei Hospital
Countries: Italy; Malta
Enrollment: 25000
Age range: 12 Years - None
Sex: ALL

Summary:
The ITAMA project, which ended in 03/2022, came from the need to increase/anticipate the number of diagnosed cases of celiac disease (CD). The project involved the preliminary development of 'software tools' (Graphical User Interface (GUI), DATABASE, Decision Support System (DSS)) used to support the physicians to optimize CD diagnosis. Subsequently, through a screening of about 20,000 subjects of school age in Malta and about 1,000 subjects in Sicily, it was shown that, in compliance with international guidelines, it is possible to anticipate CD diagnosis and make it easy with the aid of a tool based on the search for specific antibodies in the blood, collecting a single drop of blood - with a test performed directly "in the points where care is provided" (eg schools, outpatient clinics) that is with a Point-of-Care-Test (PoCT). This system proved to be effective, and the method was minimally invasive (at least in some pediatric cases it was possible to avoid the endoscopic examination).

The ITAMA project has made it possible to bring out a submerged part of the "CD iceberg", a condition that in a large percentage of cases remains undiagnosed and transfer the know-how to commercial companies in the medical sector.

ITAMA project results allowed to verify and validate, on a large sample of subjects subjected to screening, that:

1. Diagnosis can be anticipated and facilitated by combined use of a rapid test (PoCT), medical history (supported by software) and traditional serological tests.
2. The diagnosis can be optimized by the support of Information Technology (IT) tools based on Artificial Intelligence (AI).
3. Non-invasive methods, if correctly applied, allow CD diagnosis avoiding invasive diagnostic techniques.
4. The reported procedures grant considerable savings for the National Health System (NHS).

Starting from the results of ITAMA, this capitalization project aims to extend the previous experience in a larger population with heterogeneous characteristics (both adults and children).

The goal of the new project is to use the combination of PoCT + tools software, to increase/anticipate CD diagnosis and, therefore, bring the number of diagnosed subjects closer to the number of expected cases, in Sicily and Malta. The inevitable implication of this would be the improvement in the quality of life of patients (reduction of symptoms, fewer medical visits and instrumental examinations performed, reduction of lost working days, improvement of social relations) and a significant reduction in costs for the NHS.

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.

Outcomes:
Identification of subjects testing positive to PoCT.; Identification of subjects with probable CD by the use of software tools; Identification of patients positive to CD serological markers (IgA anti-tTg); Identification of patients positive to CD serological markers (IgG anti-tTg); Identification of patients positive to CD serological markers (EmA); Identification of patients positive to CD histology