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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06318598
Recruitment Status : Recruiting
First Posted : March 19, 2024
Last Update Posted : March 19, 2024
Sponsor:
Collaborators:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Ospedale San Raffaele
Information provided by (Responsible Party):
Istituto Auxologico Italiano

Tracking Information
First Submitted Date March 8, 2024
First Posted Date March 19, 2024
Last Update Posted Date March 19, 2024
Actual Study Start Date April 11, 2023
Estimated Primary Completion Date April 10, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2024)
  • genetic screening [ Time Frame: baseline (at diagnosis) ]
    no. of patients with ALS-associated mutations
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 15, 2024)
  • clinical assessment [ Time Frame: baseline (at diagnosis), at 6 months, at 1 year ]
    no. of patients with increasing vs decreasing PUMNS/LMNS scores
  • neuropsychological assessment [ Time Frame: baseline (at diagnosis), at 1 year ]
    no. of patients with increasing vs decreasing ECAS scores
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
Official Title Dissezione Fenotipica Guidata da Biomarcatori Della Sclerosi Laterale Amiotrofica/Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
Brief Summary

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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, plasma, serum, CSF
Sampling Method Non-Probability Sample
Study Population Consecutive cohort of incident patients from three Italian ALS Centers
Condition
  • Amyotrophic Lateral Sclerosis
  • Motor Neuron Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 15, 2024)		 200
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 10, 2026
Estimated Primary Completion Date April 10, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Nicola Ticozzi, MD, PhD +390261911 ext 2937 n.ticozzi@auxologico.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT06318598
Other Study ID Numbers 23M202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Istituto Auxologico Italiano
Original Responsible Party Same as current
Current Study Sponsor Istituto Auxologico Italiano
Original Study Sponsor Same as current
Collaborators
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Ospedale San Raffaele
Investigators Not Provided
PRS Account Istituto Auxologico Italiano
Verification Date March 2024