Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526364
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Clinnova-MS A Prospective Cohort Study of Patients With Multiple Sclerosis Switzerland
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinnova-MS a Prospective Cohort Study of Patients With Multiple Sclerosis A Trans-Regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care Switzerland
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective cohort study is part of the Clinnova programme and aims to i identify clinical imaging and omics characteristics associated with early Multiple Sclerosis MS and with transitioning phases to progressive MS as well as ii to investigate digital biomarkers allowing the continuous clinical monitoring of those patients
Detailed Description:
Multiple Sclerosis MS is a chronic disease of the central nervous system that causes a range of neurological symptoms such as cognitive issues fatigue vision problems and muscle weakness There are two main forms relapsing-remitting MS RRMS with episodes of symptoms that improve on their own and primary progressive MS PPMS with chronically worsening symptoms Many RRMS patients eventually develop secondary progressive MS SPMS where disability worsens without remissions What causes MS remains unknown but it is thought to involve genetic and environmental factors Diagnosis and monitoring typically involve patient history neurologic examination in combination with magnetic resonance imaging MRI and other tests but these methods are costly and time-consuming Efforts are made to develop digital tools for continuous patients monitoring
This study is part of the Clinnova programme aiming to collect standardized and high-quality digital health data Clinnova-MS is a prospective cohort study including patients with early MS or those transitioning to progressive MS Up to 100 patients recruited from the ongoing Swiss MS cohort study are enrolled in Basel Switzerland An equivalent number of patients are enrolled in other Clinnova centers reaching at least 800 patients in total The study aims to provide a structured and standardized highly granular dataset allowing for the phenotyping of patients with similar patterns and disease courses It also facilitates transnational data linkage the analysis of complex and heterogeneous data from MS patients
The primary objective of the study is to derive a set of biomarkers that will better characterize the clinical phenotype and progression of the disease as well as the functional impairment of MS patients at different stages These biomarkers will aid clinicians in making informed treatment decisions for patients with early MS or those transitioning to progressive MS
This study is part of the Clinnova programme aiming to collect standardized and high-quality digital health data Clinnova-MS is a prospective cohort study including patients with early MS or those transitioning to progressive MS Up to 100 patients recruited from the ongoing Swiss MS cohort study are enrolled in Basel Switzerland An equivalent number of patients are enrolled in other Clinnova centers reaching at least 800 patients in total The study aims to provide a structured and standardized highly granular dataset allowing for the phenotyping of patients with similar patterns and disease courses It also facilitates transnational data linkage the analysis of complex and heterogeneous data from MS patients
The primary objective of the study is to derive a set of biomarkers that will better characterize the clinical phenotype and progression of the disease as well as the functional impairment of MS patients at different stages These biomarkers will aid clinicians in making informed treatment decisions for patients with early MS or those transitioning to progressive MS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None