protocolSection identificationModule nctId: NCT06280755, orgStudyIdInfo id: ICO-S-002, briefTitle: Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study., acronym: RECLAIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: icometrix, class: INDUSTRY, collaborators name: Charite University, Berlin, Germany, collaborators name: Ruhr University of Bochum, collaborators name: Technische Universität Dresden, collaborators name: University Hospital, Lille, collaborators name: Casa di Cura IGEA, collaborators name: General University Hospital, Prague, collaborators name: Hoffmann-La Roche, collaborators name: Bristol-Myers Squibb, collaborators name: Imcyse SA, collaborators name: AB Science, collaborators name: Nocturne UG, collaborators name: Aalto University, descriptionModule briefSummary: The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease course and treatment response in a real-world setting. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression., conditionsModule conditions: Multiple Sclerosis, conditions: NMO Spectrum Disorder, conditions: Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, conditions: Radiologically Isolated Syndrome, conditions: Clinically Isolated Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 7000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The number of patients from each institution who have contributed data to the database., primaryOutcomes measure: The number of patients from each institution whose data was mapped to the common data model of the harmonised database., primaryOutcomes measure: The number of patients from the control arms of clinical trials who have contributed data to the database., primaryOutcomes measure: The data completeness of each variable in the harmonised database., secondaryOutcomes measure: The representativeness of the harmonised dataset for the MS patient population as evaluated by age range, gender balance, the distribution of country of residence, the distribution of race/ethnicity and the distribution of educational level, secondaryOutcomes measure: The validity of the data through an assessment of the amount of erroneous or impossible data entries for each variable., secondaryOutcomes measure: The temporal uniformity of each institution's data over time as assessed by the number of changes to variables over time (addition of new variables or variables no longer being captured, alterations to how variables are captured)., secondaryOutcomes measure: The temporal uniformity of the harmonised dataset over time as assessed by the average time between subsequent assessments of each variable., secondaryOutcomes measure: The presence of contextual information on standard data gathering and analysis processes of each institution, secondaryOutcomes measure: The presence of a unique and pseudonymised patient ID for all data of each patient, allowing to link such data of each patient., secondaryOutcomes measure: The temporal uniformity of MRI data over time as assessed by the comparability of MRI scans and the average time between subsequent MRI assessments for each patient., secondaryOutcomes measure: The percentage of MRI data sets which are compliant with the MAGNIMS-CMSC-NAIMS acquisition guidelines., secondaryOutcomes measure: The percentage of MRI data sets for which the automated quality control process of icobrain ms did not indicate any quality issues upon analysis., secondaryOutcomes measure: The percentage of patients with a complete disease modifying treatment history available, from the date of diagnosis to the current day., secondaryOutcomes measure: The percentage of patients with a complete disease history available, from the date of diagnosis to the current day., secondaryOutcomes measure: The validity and temporal uniformity for disability assessment as clinically determined by EDSS, Functional systems score, T25FWT, 9HPT and SDMT., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False