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El ensayo clínico NCT07479017 (SLA-PlaQ) para ELA (esclerosis lateral amiotrófica) está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Characterization of Platelet Molecular Profiles in ALS for the Identification of Specific Diagnostic Biomarkers - A Pilot Study (SLA-PlaQ) 60 Basado en biomarcadores
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07479017 (SLA-PlaQ) es un estudio observacional para ELA (esclerosis lateral amiotrófica). Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de abril de 2026 hasta completar 60 participantes. Dirigido por University Hospital, Tours, se espera que finalice el 1 de agosto de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 18 de marzo de 2026.
Resumen
The search for diagnostic biomarkers that can be used routinely is a major challenge to manage Amyotrophic lateral sclerosis (ALS) in order to characterize the pathophysiology and accelerate the management of the disease. Some non-specific biomarkers have been proposed (Neurofilaments, TDP-43) but their diagnostic value remains controversial. This study aims to identify ALS-specific platelet biomarkers using targeted...Mostrar más
Descripción detallada
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by progressive loss of motor neurons, leading to increasing muscle paralysis. The pathophysiology of ALS remains poorly understood, and the absence of a diagnostic test makes this disease a real challenge, requiring an average of 12 months before a reliable ALS diagnosis can be established. Yet, this disease progresses rapidly, leading t...Mostrar más
Título oficial
Characterization of Platelet Molecular Profiles in ALS for the Identification of Specific Diagnostic Biomarkers - A Pilot Study
Condiciones médicas
ELA (esclerosis lateral amiotrófica)Otros ID del estudio
- SLA-PlaQ
- DR250240 - SLA-PlaQ
Número del NCT
Inicio del estudio (real)
2026-04
Última actualización
2026-03-18
Fecha de finalización (estimada)
2027-08
Inscripción (prevista)
60
Tipo de estudio
Observacional
Estado general
Aún no recluta
Palabras clave
diagnostic biomarkers
platelet molecular profiles
platelet molecular profiles
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ALS patients Biological:
A blood sample will be taken at the time of inclusion by increasing the volume taken for the health routine care. | N/A |
control patients with another motor neuron disease Biological:
A blood sample will be taken at the time of inclusion by increasing the volume taken for the health routine care. | N/A |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Diagnostic potential of platelet biomarkers | Platelet biomarkers will be sought using targeted (TDP-43) and non-targeted multiomics screening approaches (transcriptomic, proteomic, metabo-lipidomic). The identified biomarkers will be integrated into multivariate models to evaluate their diagnostic potential in distinguishing ALS from other motor neuron diseases (sensibility, specificity, positive or negative predictive value). | Enrollment (< 3 months post-diagnosis) |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Diagnostic performances of platelet biomarkers compared to plasma neurofilaments | Plasma neurofilament concentration will be measured in each participant's sample. Diagnostic potential of platelet biomarkers will be compared to that of plasma neurofilaments concentration. The platelet biomarkers previously identified and plasma neurofilament concentration will be integrated into multivariate models to evaluate and compare their diagnostic potential in distinguishing ALS from other motor neuron diseases. | Enrollment (<3 months post-diagnosis) |
Relationships between platelet biomarkers, neurofilaments and clinical characteristics | To better understand the pathophysiology of ALS, relationships with clinical characteristics will be investigated: weight, height, medical history, ALSFRS-r, King's and Milano-Torino scales, Forced Vital Capacity, symptom onset, site of onset, age of onset and concomitant treatments. | Enrollment (<3 months post-diagnosis) |
Discriminatory capacity of platelet molecular signatures | The capacity to discriminate distinct clinical endophenotype of ALS patients according to platelet molecular signatures will be evaluated using multivariate models. | Enrollment (<3 months post-diagnosis) |
Prognostic value of platelets biomarkers at diagnosis on ALS functional rating scale (ALSFRS-R) score progression after one year | Capacity of platelet biomarkers measured within 3 months post-diagnosis to predict functional progression of ALS (i.e. the percentage change in ALSFRS-R score between diagnosis and one year later) | Functional evolution between enrolment (<3months post-diagnosis) and 12 months |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Patients with ALS:
- Men or women aged 18 to 75
- ALS diagnosed according to the El Escorial criteria
- ALS diagnosis less than 3 months ago
- Onset of symptoms defined as the time when muscle weakness was first observed by the patient less than 2 years ago
Controls with another motor neuron disease:
- Men or women aged 18 to 75
- Diagnosis of motor neuron disease < 3 months
- Genetic variants associated with ALS
- Pregnant or breastfeeding women
- Treatment with oral or injectable anticoagulants, antiplatelet agents (EXCEPT aspirin at the maximum authorized dosage of 160 mg per day)
- Uncontrolled diabetes
- Persons deprived of their liberty by judicial or administrative decision
- Persons subject to legal protection measures: guardianship or curatorship
- Opposition to data processing
University Hospital, ToursContactos centrales del estudio
Contacto: Hélène BLASCO, Pr, 234378911, [email protected]
Contacto: Noémie EYRAUD, 247478060, [email protected]
3 Centros del estudio en 1 países
University hospital, Limoges, Limoges, 87000, France
Philippe COURATIER, Pr, Contacto, 555056559, [email protected]
Philippe COURATIER, Pr, Investigador principal
University hospital, Lyon, Lyon, 69000, France
Emilien BERNARD, Dr, Contacto, +33472357218, [email protected]
Emilien BERNARD, Dr, Investigador principal
university hospital, Tours, Tours, 37044, France
Philippe CORCIA, Pr, Contacto, 247473724, [email protected]
Philippe CORCIA, Pr, Investigador principal