About this trial
The progress of ALS research and clinical practice is hampered by lack of effective biomarkers to monitor disease onset and progression. In response to this urgent need, we will integrate single-cell system biology approaches, histopathological and clinical data from precious human nerve biopsies collected from living ALS patients during the diagnostic workup and findings from innovative preclinical mouse models to unmask cell-specific molecular alterations that arise in the PNS tissue during the course of ALS pathology. This information will be used to select protein biomarkers of dysfunctional states associated with pre-manifest or early symptomatic stages of the disease, which will be further screened and validated in patient biofluids. Altogether, this project will lead to the discovery of novel, reliable and specific ALS biomarkers while providing insights into ALS mechanisms by leveraging an original "PNS perspective" on disease pathogenesis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age equal or over 18 years old
ALS patients, diagnosed accordingly to the revised El Escorial Criteria
Disease duration <24 months from symptom onset.
Disqualifiers
FVC <60%;
nutritional or respiratory failure;
significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.
Age equal or over 18 years old
Trial population
Number of patients projected for: * the entire study: 400 patients * each treatment group: ALS 150, HC 40, non-ALS neurodegenerative 60, non-ALS neuromuscular diseases 50, Indipendent cohort of ALS Sardinian patients 100.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Diagnostic ALS biomarkers
Throughout the study, we will validate, starting from transcriptomics data, novel diagnostic biomarker for an early diagnosis of ALS
Secondary outcomes
Prognostic biomarkers
explore novel prognostic biomarkers, able to reliably predict the time-course of ALS
Therapeutic targets
identify molecular targets related to axonal degeneration for potential therapeutic intervention
Sponsors and contacts
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead sponsor
Azienda Ospedaliero Universitaria di Cagliari
Collaborator
IRCCS San Raffaele
Collaborator
Federico II University
Collaborator