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NCT07706270Not yet recruiting

Serum Neurofilaments in the Diagnosis of Amyotrophic Lateral Sclerosis

Diagnostic Performance of Serum Neurofilaments in the Differential Diagnosis of Amyotrophic Lateral Sclerosis

Source: ClinicalTrials.gov · Last updated 20 Jul 2026

Brief summary (registry, in English)

Amyotrophic lateral sclerosis (ALS) is a serious neurodegenerative disease, often difficult to diagnose due to symptoms similar to other neurological pathologies. Diagnosis can take up to 14 months, although the rapid progression of the disease requires early detection. At present, there is no validated biomarker to aid diagnosis. Serum neurofilaments light chain (NfL), markers of neuronal degeneration, show great potential to help diagnose ALS early and assess disease severity. Recent research has shown that measurement of NfL in the blood can differentiate ALS from other neurological disorders, and new technologies are increasingly making it possible to perform these tests clinically. The study hypothesis is that NfL blood levels, measured using clinical analyzers, could improve early ALS diagnosis, optimize patient recruitment for therapeutic trials and accelerate the assessment of treatment efficacy. The primary objective is to evaluate the sensitivity and specificity of serum NfL for the diagnosis and differential diagnosis of amyotrophic lateral sclerosis (ALS) in newly recruited patients referred to the ALS Reference Center at Montpellier University Hospital. The diagnosis is established according to the revised El Escorial diagnostic criteria (see Appendix). This diagnosis is determined independently of the serum NfL concentration.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
138 (estimated)
First submitted
10 Jul 2026
Start date
1 Aug 2026
Primary completion date
1 Aug 2027
Lead sponsor
University Hospital, Montpellier
NCT number
NCT07706270

What you commit to

  • Study type: Observational
  • Planned participants: 138
  • From 1 Aug 2026 to the primary completion date, 1 Aug 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • -• Patients with recent stroke
  • Failure to obtain written informed consent after a period of reflection

Other

  • Pregnant or breast-feeding women
  • Patient deprived of liberty by judicial or administrative decision, or hospitalization under duress
  • Adult protected by law (guardianship, curatorship)
  • Patient unable to understand and read information and consent forms in French
  • Person participating in another research study with an exclusion period still in progress.
  • Not affiliated to a social security scheme or beneficiary of such a scheme
  • Person unable to give consent

Who the study is looking for

  • Be at least 18 years of age
  • Be able to undergo blood sampling (however, blood sampling is part of the standard examination and will not be performed exclusively for this study).
  • Patients with suspected ALS

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.