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Neurofilament Assay for the Diagnosis of ALS

NCT ID: NCT05077696

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-11-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Progressive Motor Neuron Disease Without Definite Diagnosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with progressive motor neuron disease without definite diagnosis

Patients with progressive motor neuron disease without definite diagnosis

Drawing a tube of blood (serum)

Intervention Type OTHER

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

Interventions

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Drawing a tube of blood (serum)

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

Intervention Type OTHER

Eligibility Criteria

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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


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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Maria del Mar Amador

Role: CONTACT

[email protected]
1 42 16 24 72 ext. +33

Other Identifiers

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2021-A02460-41

Identifier Type: OTHER

Identifier Source: secondary_id

APHP210917

Identifier Type: -

Identifier Source: org_study_id