Biostaging: Staging System in Amyotrophic Lateral Sclerosis

Sponsor

University Hospital, Limoges (Other)

Overall Status

Recruiting

CT.gov ID

NCT04858555

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Staging System in Amyotrophic Lateral Sclerosis

Actual Study Start Date :

May 2, 2022

Anticipated Primary Completion Date :

May 2, 2024

Anticipated Study Completion Date :

May 2, 2024

Outcome Measures

Primary Outcome Measures

To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers. [2 years]
To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.