Study Purpose:
Recently two staging systems have been proposed for amyotrophic lateral sclerosis (ALS), based on clinical milestones The King's college clinical staging system (1) and ALS Milano-Torino Staging (ALS-MITOS) (2). Further research to validate and develop an accurate staging system in different populations will improve our understanding of its pathogenesis, disease activity and progression.General objective : To validate the two previously proposed staging system and to test the interest of considering Neurofilament biomarkers in these systems.
Specific objectives: 1) To validate the two classification systems in an independent cohort of patients with ALS followed-up in the ALS expert center of Limoges (France) 2) To assess the interest of Nf biomarkers to predict neurological decline
Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Philippe Couratier, Pr / email hidden; JavaScript is required / 00335 55 05 65 61
Full Study Summary:
Amyotrophic lateral sclerosis (ALS) is a rare, fatal neurodegenerative disease of the human motor system. Recently two new staging systems have been proposed for ALS, based on clinical milestones related also to the spreading pattern of the disease (1,2). Furthermore, biomarker development is still an essential component of future therapeutic development in ALS. Thus, it is also important to acknowledge the value of biomarker research in supporting or revealing fundamental pathophysiological mechanisms in ALS.
The proposed staging systems: have been recently tested in two independent cohorts (3,4) with results that were not fully consistent (ii) did not considered the potential value of biomarkers.
The proposed staging systems: have been recently tested in two independent cohorts (3,4) with results that were not fully consistent (ii) did not considered the potential value of biomarkers.
Study Sponsor:
University Hospital, Limoges
Estimated Enrollment:
50
Estimated Study Start Date:
12 / 02 / 2022
Estimated Study Completion Date:
12 / 02 / 2024
Posting Last Modified Date:
03 / 21 / 2023
Date Study Added to neals.org:
04 / 26 / 2021
Minimum Age:
N/A
Maximum Age:
N/A
Inclusion Criteria:- ALS cases recruited for retrospectively (between) 2007 to 2016 for the retrospective cohort
- ALS cases recruited for prospectively by the ALS expert center of Limoges for one year.
Exclusion Criteria:
- Previous neurosurgical operations
- A recent history of neurotrauma
- Peripheral neuropathies
- ALS/frontotemporal dementia (ALS/FTD)
Limoges University Hospital | Recruiting
Philippe COURATIER, Pr
Limoges 87042
France
Tours University Hospital | Recruiting
Philippe CORCIA, Pr / 0033247473724 / email hidden; JavaScript is required
Tours 37044
France