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Neurofilament Assay for the Diagnosis of ALS (FILSLAN-NF)

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: NCT05077696
Recruitment Status : Not yet recruiting
First Posted : October 14, 2021
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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
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
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Study Type : Observational
Estimated 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
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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.


Outcome Measures
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Primary Outcome Measures :
  1. contribution of pNFH and NFL neurofilaments assays [ Time Frame: 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 :
  1. Value of the combined pNFH and NFL neurofilament assay in serum versus the pNFH and NFL assay alone [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with progressive motor neuron disease without a definite diagnosis.
Criteria

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

Non-inclusion criteria:

Refusal of the patient Person under a legal protection measure (guardianship, curatorship or safeguard of justice).

Person deprived of liberty by judicial or administrative decision.

Contacts and Locations
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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): NCT05077696


Contacts
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Contact: Maria del Mar Amador 1 42 16 24 72 ext +33 mariadelmar.amador@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05077696    
Other Study ID Numbers: APHP210917
2021-A02460-41 ( Other Identifier: IDRCB )
First Posted: October 14, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: September 2021

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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 Assistance Publique - Hôpitaux de Paris:
ALS
Neurofilaments
NFL
 pNFH
Amyotrophic Lateral Sclerosis
progressive motor neuron disease
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases