Staging System in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

— Biostaging  

Official title:

Staging System in Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04858555
• Other study ID #: I16017_1 (Biostaging)
• Status: Recruiting
• Start date: December 2, 2022
• Est. completion date: December 2, 2024

Study information

• Verified date: June 2023
• Source: University Hospital, Limoges
• Contact: Philippe Couratier, Pr
• Phone: 00335 55 05 65 61
• Email: Philippe.Couratier[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2, 2024
• Est. primary completion date: December 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Locations

Country	Name	City	State
France	Limoges University Hospital	Limoges
France	Tours University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers.	To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers	2 years