Translating Single-cell Vulnerability Into Novel ALS Biomarkers and Therapeutic Targets: Towards a Liquid Nerve Biopsy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 5 trial groups
Group A: 1
Group B: 2
Group C: 3
Group D: 4
Group E: 5

Trial outcomes

Primary outcomes

1

Diagnostic ALS biomarkers

Throughout the study, we will validate, starting from transcriptomics data, novel diagnostic biomarker for an early diagnosis of ALS

Time frame
20 months

Secondary outcomes

1

Prognostic biomarkers

explore novel prognostic biomarkers, able to reliably predict the time-course of ALS

Time frame
24 months
2

Therapeutic targets

identify molecular targets related to axonal degeneration for potential therapeutic intervention

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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