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

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

Tracking Information

• First Submitted Date: October 1, 2021
• First Posted Date: October 14, 2021
• Last Update Posted Date: October 14, 2021
• Estimated Study Start Date: November 1, 2021
• Estimated Primary Completion Date: November 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 1, 2021)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 1, 2021)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neurofilament Assay for the Diagnosis of ALS
• 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
• 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.
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

serum

• Sampling Method: Non-Probability Sample
• Study Population: Patients with progressive motor neuron disease without a definite diagnosis.
• Condition: Progressive Motor Neuron Disease Without Definite Diagnosis

Intervention

Other: Drawing a tube of blood (serum)

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

Study Groups/Cohorts

Patients with progressive motor neuron disease without definite diagnosis

Patients with progressive motor neuron disease without definite diagnosis

Intervention: Other: Drawing a tube of blood (serum)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 1, 2021): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 1, 2023
• Estimated Primary Completion Date: November 1, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05077696
• Other Study ID Numbers: APHP210917; 2021-A02460-41 ( Other Identifier: IDRCB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: September 2021