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Staging System in Amyotrophic Lateral Sclerosis (Biostaging)

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ClinicalTrials.gov Identifier: NCT04858555
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

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
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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Staging System in Amyotrophic Lateral Sclerosis
Actual Study Start Date : May 2, 2022
Estimated Primary Completion Date : May 2, 2024
Estimated Study Completion Date : May 2, 2024





Primary Outcome Measures :
  1. To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers. [ Time Frame: 2 years ]
    To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers


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


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with ALS, followed-up in the ALS expert center of Limoges university Hospital (France).
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858555


Contacts
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Contact: Philippe Couratier, Pr 00335 55 05 65 61 Philippe.Couratier@chu-limoges.fr
Contact: Jaime LUNA, PhD 00335 55 05 65 61 jaimeandreslunam@gmail.com

Locations
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France
Limoges University Hospital Recruiting
Limoges, France, 87042
Contact: Philippe COURATIER, Pr         
Sponsors and Collaborators
University Hospital, Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT04858555    
Other Study ID Numbers: I16017_1 (Biostaging)
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
Amyotrophic Lateral Sclerosis
ALS
Staging
Biomarker
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases