Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05715970
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-01-18
Brief Title:
ICT Tools for the Diagnosis of Autoimmune Diseases
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
ICT Tools for the Diagnosis of Autoimmune Diseases in the Mediterranean Area_CAPITALISATION PROJECT
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITAMA_CAP
Brief Summary:
The ITAMA project which ended in 032022 came from the need to increaseanticipate 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 20000 subjects of school age in Malta and about 1000 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 increaseanticipate 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 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 increaseanticipate 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
Detailed Description:
Background The diagnosis of celiac disease CD a known autoimmune disease presupposes the recognition of symptomssigns the carrying out of serological tests and the diagnostic confirmation with histological examination of intestinal biopsies The pediatric guidelines European Society for Pediatric Gastroenterology Hepatology and Nutrition report the possibility of avoiding biopsy in some classes of pediatric patients It is estimated that about 1 of the world population is affected by CD but only 037 of the Italian population and 040 in Malta to date has been diagnosed In Sicily in particular the cases not yet diagnosed are probably even more than in the rest of the Italian territory because the prevalence was slightly lower than the national average 035 It is clear from these data that CD is an underestimated pathology throughout the national territory and even more in Sicily It is also known that CD is associated with various pathologies with an autoimmune component including type 1 diabetes mellitus and Hashimotos thyroiditis and that among its complications more present in subjects who do not practice or are refractory to a gluten-free diet neoplastic diseases are also included such as intestinal T-cell lymphoma and small intestine adenocarcinoma
The ITAMA project which ended in March 2022 was born from the need to increaseanticipate the number of diagnosed cases of CD by optimizing its diagnosis The project has developed software tools Graphical User Interface GUI DATABASE Decision Support System DSS to support the physicians in optimizing CD diagnosis Through a screening conducted on 20000 school-age subjects in Malta and about 1000 subjects in Sicily it was demonstrated that in compliance with the European Society Paediatric Gastroenterology Hepatology and Nutrition guidelines it was possible to anticipate the diagnosis of CD and make it easy with the aid of a test performed directly at the points where treatment is provided eg schools medical clinics ie with a Point-of-Care-Test PoCT Celiac Disease Quick TestBIOHIT HealthCare Srl Milan Italy conducted on capillary blood obtained through simple and low cost finger prick This system has proved to be an effective and the method to be minimally invasive and inexpensive making it possible at least in certain pediatric cases to bring out a submerged part of the CD iceberg avoiding further investigations even invasive in patients with negative PoCT With ITAMA it was therefore possible to transfer the know-how to commercial companies in the medical sector activating a network between research and production areas in the healthcare sector through the development of information and communication technologies ICT for the diagnosis of the CD The results made it possible to verifyvalidate on a large sample of subjects that
the diagnosis can be anticipatedfacilitated through the combined use of a rapid test PoCT medical history and traditional serological tests
the diagnosis can be optimized thanks to the support of computer tools based on artificial intelligence AI
The capitalization of the aforementioned results is probably possible through the National Health System NHS and schools and could be strategic because
non-invasive methods if correctly applied allow an early and effective diagnosis of CD currently underdiagnosed and in some cases can also allow patients not to be subjected to invasive diagnostic methods
the aforementioned procedures allow a considerable saving for the NHS
Objectives The present project aims to capitalize and extend the previous experience of ITAMA in a larger population with heterogeneous characteristics young people and adults through the Sicilian network of General Practitioners GPs and the involvement of numerous schools in Malta
The goal is to use ITAMA outputsresults to increaseanticipate the diagnosis of CD and therefore bring the number of diagnosed subjects closer to the expected number of CD cases in Sicily and Malta The consequence could be the improvement of the quality of life of the diagnosed patients anticipation of diagnosis and therapy with consequent reduction of symptomssigns reduction of medical visitsinstrumental tests performed reduction of lost working days improvement of social relationships and a significant reduction in costs for the NHS as well as a reduction in the number of conventional tests laboratory and instrumental investigations not recommended in patients with negative PoCT and the further consequent costs caused by these
Expected results The expected results from this extension of the ITAMA project would essentially consist in the capitalization of the previously observed results through A the involvement of the Sicilian network of GPs and Maltese schools and their greater knowledge and awareness of the need to bring out the diagnoses miss you today B the confirmation of a possible and extensive outpatient use of the PoCT method to facilitate diagnosis
From a clinical point of view we also expect 1 an increase in CD diagnoses bridging the gap between diagnosed cases and estimated cases also showing any differences in prevalence between adults and children 2 a reduction in diagnostic delays with a consequent improvement in the quality of life of patients and a reduction in costs for the NHS 3 a reduction in the number of conventional tests laboratory and instrumental investigations not recommended in patients with negative PoCT and in the further consequent costs caused by these
From a scientific point of view this study will contribute to 1 define more precisely the prevalence of CD in two populations of the Mediterranean area 2 create a database usable by researchers for this and future research 3 to demonstrate the utility of a minimally invasive and low-cost screening test for the early identification of patients with CD
The ITAMA project which ended in March 2022 was born from the need to increaseanticipate the number of diagnosed cases of CD by optimizing its diagnosis The project has developed software tools Graphical User Interface GUI DATABASE Decision Support System DSS to support the physicians in optimizing CD diagnosis Through a screening conducted on 20000 school-age subjects in Malta and about 1000 subjects in Sicily it was demonstrated that in compliance with the European Society Paediatric Gastroenterology Hepatology and Nutrition guidelines it was possible to anticipate the diagnosis of CD and make it easy with the aid of a test performed directly at the points where treatment is provided eg schools medical clinics ie with a Point-of-Care-Test PoCT Celiac Disease Quick TestBIOHIT HealthCare Srl Milan Italy conducted on capillary blood obtained through simple and low cost finger prick This system has proved to be an effective and the method to be minimally invasive and inexpensive making it possible at least in certain pediatric cases to bring out a submerged part of the CD iceberg avoiding further investigations even invasive in patients with negative PoCT With ITAMA it was therefore possible to transfer the know-how to commercial companies in the medical sector activating a network between research and production areas in the healthcare sector through the development of information and communication technologies ICT for the diagnosis of the CD The results made it possible to verifyvalidate on a large sample of subjects that
the diagnosis can be anticipatedfacilitated through the combined use of a rapid test PoCT medical history and traditional serological tests
the diagnosis can be optimized thanks to the support of computer tools based on artificial intelligence AI
The capitalization of the aforementioned results is probably possible through the National Health System NHS and schools and could be strategic because
non-invasive methods if correctly applied allow an early and effective diagnosis of CD currently underdiagnosed and in some cases can also allow patients not to be subjected to invasive diagnostic methods
the aforementioned procedures allow a considerable saving for the NHS
Objectives The present project aims to capitalize and extend the previous experience of ITAMA in a larger population with heterogeneous characteristics young people and adults through the Sicilian network of General Practitioners GPs and the involvement of numerous schools in Malta
The goal is to use ITAMA outputsresults to increaseanticipate the diagnosis of CD and therefore bring the number of diagnosed subjects closer to the expected number of CD cases in Sicily and Malta The consequence could be the improvement of the quality of life of the diagnosed patients anticipation of diagnosis and therapy with consequent reduction of symptomssigns reduction of medical visitsinstrumental tests performed reduction of lost working days improvement of social relationships and a significant reduction in costs for the NHS as well as a reduction in the number of conventional tests laboratory and instrumental investigations not recommended in patients with negative PoCT and the further consequent costs caused by these
Expected results The expected results from this extension of the ITAMA project would essentially consist in the capitalization of the previously observed results through A the involvement of the Sicilian network of GPs and Maltese schools and their greater knowledge and awareness of the need to bring out the diagnoses miss you today B the confirmation of a possible and extensive outpatient use of the PoCT method to facilitate diagnosis
From a clinical point of view we also expect 1 an increase in CD diagnoses bridging the gap between diagnosed cases and estimated cases also showing any differences in prevalence between adults and children 2 a reduction in diagnostic delays with a consequent improvement in the quality of life of patients and a reduction in costs for the NHS 3 a reduction in the number of conventional tests laboratory and instrumental investigations not recommended in patients with negative PoCT and in the further consequent costs caused by these
From a scientific point of view this study will contribute to 1 define more precisely the prevalence of CD in two populations of the Mediterranean area 2 create a database usable by researchers for this and future research 3 to demonstrate the utility of a minimally invasive and low-cost screening test for the early identification of patients with CD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None