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

NCT07268833 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-12-08

No results posted yet for this study

Summary

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.

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)
  • Peripheral Neuropathies

Sponsors & Collaborators

  • Azienda Ospedaliero Universitaria di Cagliari

    collaborator OTHER

  • IRCCS San Raffaele

    collaborator OTHER

  • Università di Napoli Federico II

    collaborator UNKNOWN

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07268833 on ClinicalTrials.gov