Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis (DRIVEALS)

March 15, 2024 updated by: Istituto Auxologico Italiano

Dissezione Fenotipica Guidata da Biomarcatori Della Sclerosi Laterale Amiotrofica/Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis

The goal of this observational study is to understand the clinical variability in a population of ALS patients using multidimensional biomarkers. The main questions it aims to answer are:

  • Which set of biomarkers explain genotypic-phenotypic correlations in ALS?
  • Which set of biomarkers can be used to subdivide the ALS population in homogeneous subgroups?

Participants will undergo:

  • neurological evaluation
  • neurophysiological evaluation
  • neuropsychological evaluation
  • whole exome sequencing
  • biomarker measurement in CSF and plasma

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Contact:
          • Yuri Falzone, MD, PhD
      • Milano, MI, Italy, 20149
        • Recruiting
        • Ospedale San Luca
        • Contact:
    • TO
      • Torino, TO, Italy, 10126
        • Recruiting
        • AOU Città della Salute e della Scienza
        • Contact:
          • Adriano Chiò, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive cohort of incident patients from three Italian ALS Centers

Description

Inclusion Criteria:

  • diagnosis of ALS or other motor neuron disease
  • residence near the study centers

Exclusion Criteria:

  • refusal to participate to the study
  • unable/unwilling to perform follow-up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
genetic screening
Time Frame: baseline (at diagnosis)
no. of patients with ALS-associated mutations
baseline (at diagnosis)
biomarker assessment
Time Frame: baseline (at diagnosis), at 6 months, at 1 year
no. of patients with abnormal NfL, GFAP, tau, UCHL1, MCP1 and TDP-43 levels
baseline (at diagnosis), at 6 months, at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical assessment
Time Frame: baseline (at diagnosis), at 6 months, at 1 year
no. of patients with increasing vs decreasing PUMNS/LMNS scores
baseline (at diagnosis), at 6 months, at 1 year
neuropsychological assessment
Time Frame: baseline (at diagnosis), at 1 year
no. of patients with increasing vs decreasing ECAS scores
baseline (at diagnosis), at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Collaborators

Azienda Ospedaliera Città della Salute e della Scienza di Torino
Ospedale San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2023

Primary Completion (Estimated)

April 10, 2026

Study Completion (Estimated)

April 10, 2026

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23M202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Motor Neuron Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe