FILSLAN-NF: Neurofilament Assay for the Diagnosis of ALS

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05077696

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate the interest of the determination of pNFH and NFL neurofilaments in serum for the diagnosis of ALS in patients with a diagnostic standoff after evaluation in an expert ALS center. The hypothesis is that one of these biomarkers, or their combined analysis, will make it possible to confirm or invalidate the diagnosis of ALS.

Condition or Disease	Intervention/Treatment	Phase
Progressive Motor Neuron Disease Without Definite Diagnosis	Other: Drawing a tube of blood (serum)

Detailed Description

For this study, which aims to evaluate a test to help in the diagnosis of ALS that could be integrated into routine practice, it was preferred to use blood tests. Blood sampling is significantly less invasive than CSF sampling, and more easily generalized, including in ambulatory conditions.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Contribution of the Neurofilament Assay for the Diagnosis of ALS (Amyotrophic Lateral Sclerosis) in Situations of Diagnostic Standoff After Evaluation in an Expert ALS Center

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with progressive motor neuron disease without definite diagnosis Patients with progressive motor neuron disease without definite diagnosis	Other: Drawing a tube of blood (serum) dosage of neurofilaments and comparison with a final diagnosis one year after sampling.

Arm

Intervention/Treatment

Patients with progressive motor neuron disease without definite diagnosis

Other: Drawing a tube of blood (serum)

dosage of neurofilaments and comparison with a final diagnosis one year after sampling.

Outcome Measures

Primary Outcome Measures

contribution of pNFH and NFL neurofilaments assays [1 year]
contribution of pNFH and NFL neurofilaments assays in serum for the positive diagnosis of ALS in a selected population of patients with progressive motor neuron disease without definite diagnosis

Secondary Outcome Measures

Value of the combined pNFH and NFL neurofilament assay in serum versus the pNFH and NFL assay alone [1 year]
To evaluate the value of the combined pNFH and NFL neurofilament assay in serum versus the pNFH and NFL assay alone for the positive diagnosis of ALS in a selected population of patients with progressive motor neuron disease without a definite diagnosis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria :

Subjects with first and/or second motor neuron disease, evolving clinically and/or electrically over at least 12 months, not meeting the diagnostic criteria for ALS (revised

El Escorial criteria):

Isolated peripheral motor neuron disease (at least one region of the PNM) OR
Isolated central motor neuron involvement (at least two areas of the MNC) OR
associated involvement of the MNP and MNC but in the presence of an associated pathology responsible for a persistent diagnostic doubt (double narrow cervical and lumbar canal, associated evolving cancer evoking a paraneoplastic syndrome without specific antibody found) Age superior to 18 years Management and follow-up in one of the French ALS centers Patient able to express his non-opposition Affiliation with social security or beneficiary of such a plan