The Canadian prospective cohort study to understand progression in multiple sclerosis (CanProCo): rationale, aims, and study design
- PMID: 34706670
- PMCID: PMC8549411
- DOI: 10.1186/s12883-021-02447-7
The Canadian prospective cohort study to understand progression in multiple sclerosis (CanProCo): rationale, aims, and study design
Abstract
Background: Neurological disability progression occurs across the spectrum of people living with multiple sclerosis (MS). Although there are a handful of disease-modifying treatments approved for use in progressive phenotypes of MS, there are no treatments that substantially modify the course of clinical progression in MS. Characterizing the determinants of clinical progression can inform the development of novel therapeutic agents and treatment approaches that target progression in MS, which is one of the greatest unmet needs in clinical practice. Canada, having one of the world's highest rates of MS and a publicly-funded health care system, represents an optimal country to achieve in-depth analysis of progression. Accordingly, the overarching aim of the Canadian Prospective Cohort Study to Understand Progression in MS (CanProCo) is to evaluate a wide spectrum of factors associated with the clinical onset and rate of disease progression in MS, and to describe how these factors relate to one another to influence progression.
Methods: CanProCo is a prospective, observational cohort study with investigators specializing in epidemiology, neuroimaging, neuroimmunology, health services research and health economics. CanProCo's study design was approved by an international review panel, comprised of content experts and key stakeholders. One thousand individuals with radiologically-isolated syndrome, relapsing-remitting MS, and primary-progressive MS within 10-15 years of disease onset will be recruited from 5 academic MS centres in Canada. Participants will undergo detailed clinical evaluation annually over 5 years (including advanced, app-based clinical data collection). In a subset of participants within 5-10 years of disease onset (n = 500), blood, cerebrospinal fluid, and research MRIs will be collected allowing an integrated, in-depth evaluation of factors contributing to progression in MS from multiple perspectives. Factors of interest range from biological measures (e.g. single-cell RNA-sequencing), MRI-based microstructural assessment, participant characteristics (self-reported, performance-based, clinician-assessed, health-system based), and micro and macro-environmental factors.
Discussion: Halting the progression of MS remains a fundamental need to improve the lives of people living with MS. Achieving this requires leveraging transdisciplinary approaches to better characterize why clinical progression occurs. CanProCo is a pioneering multi-dimensional cohort study aiming to characterize these determinants to inform the development and implementation of efficacious and effective interventions.
Keywords: Biology; Canada; Cohort; Epidemiology; Health systems; Imaging; Multiple sclerosis; Neuroimmunology; Progression; Progressive MS; Prospective.
© 2021. The Author(s).
Conflict of interest statement
Jiwon Oh has received research funding from Biogen-Idec and Roche, and personal fees for consulting for Biogen-Idec and Roche.
Nathalie Arbour reports no competing interests.
Fabrizio Giuliani has received honoraria from Biogen, Novartis, Roche for industry-sponsored talks, and consulting fees from Biogen and Novartis. He is the recipient of research grants from Biogen and Roche.
Melanie Guenette reports no competing interests.
Shannon Kolind has received research funding from Roche.
Larry Lynd reports no competing interests.
Ruth Ann Marrie reports no competing interests.
Luanne M. Metz reports no competing interests.
Scott B. Patten reports no competing interests.
Alexandre Prat has received research support from Biogen and Roche; has received consulting fees from Biogen-Idec and Roche.
Alice Schabas has received personal fees for consulting for Biogen-Idec and Roche.
Penny Smyth has received unrestricted research support from Biogen-Idec; and has received consulting fees and honoraria for speaking activities from Biogen-Idec and Roche.
Roger Tam holds a grant from the Praxis Spinal Cord Institute for an unrelated educational program.
Anthony Traboulsee has received research support from Sanofi Genzyme and Roche; has received consulting fees from Sanofi Genzyme, Roche, Teva Neuroscience, Novartis, Biogen and EMD Serono; and has received honoraria for his involvement in speaker bureau activities for Sanofi Genzyme and Roche.
V. Wee Yong has received honoraria from Biogen, Novartis, Roche, Sanofi-Genzyme and Teva for industry-sponsored talks, and consulting fees from EMD Serono, Roche and Sanofi-Genzyme. He is the recipient of unrestricted educational grants from Biogen, EMD Serono, Novartis, Roche, Sanofi-Genzyme and Teva to support educational activities of the Alberta MS Network, which he directs.
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