Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.

Multiple Sclerosis Clinical Trial

— RECLAIM  

Official title:

Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06280755
• Other study ID #: ICO-S-002
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: April 2027

Study information

• Verified date: February 2024
• Source: icometrix
• Contact: Jelle Praet, PhD
• Phone: +32 16 369 000
• Email: jelle.praet[@]icometrix.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

There is a clear need for a data-driven and personalized treatment optimisation tool for people with Multiple Sclerosis (MS), in order to enable/support physicians to deploy appropriate therapeutic measures that will help to better slow down disease progression and eventually, progressive disability worsening. While early diagnosis and prognostic modelling is important to make data-driven recommendations for treatment optimisation, being able to disentangle and monitor the disability accumulation due to 'relapse associated worsening' or due to 'progression independent of relapse activity' will be key to optimizing treatment for the best possible long-term outcomes. The latter strongly depends on the availability of biomarkers that can detect and differentiate between these different forms of disease worsening.

With the RECLAIM study, we focus on gathering a centralized and harmonized dataset, enabling the secondary use of data to support prognosis for people with MS, as well as treatment optimisation in a real-world setting. As such, RECLAIM aims to develop MRI-based tools to better monitor disease progression in people with MS, as well as AI-based models that will support prognosis of individual disease course and treatment response, comprising: (i) a biomarker-based MS progression model, (ii) an MRI-focused generative model to predict brain characteristic evolution, and (iii) an interventional model for treatment optimisation. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7000
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients must have a confirmed diagnosis of MS, NMOSD, MOGAD, CIS or RIS.

• Patient (or patient's legal representative) has previously signed and dated an informed consent form (ICF) for the secondary use of their data, or assent form. Alternatively, the secondary use of the patient's data is allowed following Institutional Review Board (IRB)/Ethical Committee (EC) approval in accordance with national and local subject privacy regulations.

Exclusion criteria:

• Patients under 18 years of age will be excluded.

• Other unspecified reasons that, in the opinion of the Investigator or Joint Steering Committee, make the patient unsuitable for participation in the study.

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Multiple Sclerosis
• Neuromyelitis Optica
• NMO Spectrum Disorder
• Radiologically Isolated Syndrome
• Sclerosis
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (13)

Lead Sponsor	Collaborator
icometrix	Aalto University, AB Science, Bristol-Myers Squibb, Casa di Cura IGEA, Charite University, Berlin, Germany, General University Hospital, Prague, Hoffmann-La Roche, Imcyse SA, Nocturne UG, Ruhr University of Bochum, Technische Universität Dresden, University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients from each institution who have contributed data to the database.		4 years
Primary	The number of patients from each institution whose data was mapped to the common data model of the harmonised database.		4 years
Primary	The number of patients from the control arms of clinical trials who have contributed data to the database.		4 years
Primary	The data completeness of each variable in the harmonised database.		4 years
Secondary	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		4 years
Secondary	The validity of the data through an assessment of the amount of erroneous or impossible data entries for each variable.		4 years
Secondary	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).		4 years
Secondary	The temporal uniformity of the harmonised dataset over time as assessed by the average time between subsequent assessments of each variable.		4 years
Secondary	The presence of contextual information on standard data gathering and analysis processes of each institution		4 years
Secondary	The presence of a unique and pseudonymised patient ID for all data of each patient, allowing to link such data of each patient.		4 years
Secondary	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.		4 years
Secondary	The percentage of MRI data sets which are compliant with the MAGNIMS-CMSC-NAIMS acquisition guidelines.		4 years
Secondary	The percentage of MRI data sets for which the automated quality control process of icobrain ms did not indicate any quality issues upon analysis.		4 years
Secondary	The percentage of patients with a complete disease modifying treatment history available, from the date of diagnosis to the current day.		4 years
Secondary	The percentage of patients with a complete disease history available, from the date of diagnosis to the current day.		4 years
Secondary	The validity and temporal uniformity for disability assessment as clinically determined by EDSS, Functional systems score, T25FWT, 9HPT and SDMT.	Each of these scores will be assessed individually for the amount of erroneous or impossible data entries, as well as for the average time between subsequent assessments of each variable.	4 years