Staging System in Amyotrophic Lateral Sclerosis

NCT04858555 | Active Not Recruiting

• 1 other identifier: I16017_1 (Biostaging)
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; ALS; Staging; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with ALS, followed-up in the ALS expert center of Limoges university Hospital (France).

You may qualify if:

• 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.

You may not qualify if:

• Previous neurosurgical operations
• A recent history of neurotrauma
• Peripheral neuropathies
• ALS/frontotemporal dementia (ALS/FTD)

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (2)

Limoges University Hospital

Limoges, 87042, France

Location

Tours University Hospital

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected from ALS incident cases. Neurofilaments levels will be determined in the plasma using ELISA Method

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: December 2, 2022
• Primary Completion: April 14, 2024
• Study Completion (Estimated): December 2, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

FR (2)