Staging System in Amyotrophic Lateral Sclerosis (Biostaging)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04858555|
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : June 1, 2022
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|
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 Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
- 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
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
|Contact: Philippe Couratier, Pr||00335 55 05 65 61||Philippe.Couratier@chu-limoges.fr|
|Contact: Jaime LUNA, PhD||00335 55 05 65 firstname.lastname@example.org|
|Limoges University Hospital||Recruiting|
|Limoges, France, 87042|
|Contact: Philippe COURATIER, Pr|