ICT Tools for the Diagnosis of Autoimmune Diseases

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.

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.

Sponsors & Collaborators

• University of Palermo

  lead OTHER

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2024-02-28

Completion

2024-12-31

Countries

• Italy
• Malta

Study Locations