ICT Tools for the Diagnosis of Autoimmune Diseases
Key facts
- Who runs it
- University of Palermo
- Where
- Italy and Malta2 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 25,000 people enrolled
- Started
- 1 Jun 2023
- Ended
- 31 Dec 2024
- Type of study
- Interventional
- Treatments tested
- PoCT+questionnaire administration
- Record updated
- 30 March 2025
Who can take part
- Age
- 12 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- age >12 and <18 years for subjects enrolled in Malta
- age >18 years for subjects enrolled in Sicily
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
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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.
The group in the trial
- General populationTreatment being tested
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.
Treatment: PoCT+questionnaire administration
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- ICT Tools for the Diagnosis of Autoimmune Diseases in the Mediterranean Area_CAPITALISATION PROJECT
- Record updated
- 30 March 2025