Identifying factors that predict progression in motor neuron disease
Study of Predictive Factors of Progression of Motor Neurone Disease Prognosis and Endophenotype Biomarkers French Database Set up
This study is trying to find out what signs can help predict how fast ALS will progress and how long patients can live without serious health issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 13 sites (Angers and 12 other locations) |
| Trial ID | NCT02360891 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze a cohort of 1000 patients with Amyotrophic Lateral Sclerosis (ALS), alongside neurological and healthy controls, to identify clinical, biological, imaging, and electrophysiological biomarkers that can predict disease progression and survival without severe comorbidities. The study will utilize a range of assessments including medical history, genetic analyses, and various imaging techniques to establish prognostic markers and differentiate between disease endophenotypes. By employing a large sample size, the study seeks to enhance the statistical power of its findings and improve patient stratification for future clinical trials.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with suspected Amyotrophic Lateral Sclerosis or those with other neurodegenerative diseases for control comparisons.
Not a fit: Patients under 18 years or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prognostic tools for ALS, enabling more personalized treatment approaches and improved outcomes for patients.
How similar studies have performed: While there have been numerous studies on ALS, this approach focusing on multimodal biomarkers and large cohort analysis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for ALS patients: * Patients with suspicion of Amyotrophic lateral sclerosis * Since the first signs (cramps fasciculation) or first deficit at the diagnosis work up * Patient older than 18 years * Patient able to provide informed consent Inclusion Criteria for healthy controls: * Subjects older than 18 years (matched population for age and sex with ALS) * Neurological testing and examination showing no neurological disorders. * Not having severe disease or life- functional prognosis Inclusion Criteria for neurological controls: * Patients having a typical neurodegenerative diseases other than ALS (Parkinson's disease, Alzheimer's disease) * Not having severe disease or life- functional prognosis * Patient older than 18 years (matched population for age and sex with ALS) * Patient able to provide informed consent Exclusion Criteria: * Subjects younger than 18 years * Patient unable to provide informed consent * Having severe disease or life- functional prognosis * Contraindications MRI
Where this trial is running
Angers and 12 other locations
- CHU Pontchaillou — Angers, France (Recruiting)
- CHU Cote de Nacre — Caen, France (Recruiting)
- CHU Gabriel Montpied — Clermont-Ferrand, France (Recruiting)
- CHRU, Hôpital Salengro — Lille, France (Recruiting)
- Hôpital Dupuytren — Limoges, France (Recruiting)
- Hôpital Neurologique Pierre Wertheimer — Lyon, France (Recruiting)
- AP-HM,Hôpital de la Timone — Marseille, France (Recruiting)
- Hôpital Gui de Chauliac — Montpellier, France (Recruiting)
- Hôpital de l'Archet 1, CHU — Nice, France (Recruiting)
- Hôpital La Pitié (AP-HP) — Paris, France (Recruiting)
- Centre Hospitalier — Saint Brieuc, France (Recruiting)
- Hôpital Nord — Saint Etienne, France (Recruiting)
- CHU Bretonneau — Tours, France (Recruiting)
Study contacts
- Study coordinator: David Devos, MD, PhD
- Email: david.devos@chru-lille.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.