Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis

NCT ID: NCT06318598

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-11

Study Completion Date

2026-04-10

Brief Summary

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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

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Conditions

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Amyotrophic Lateral Sclerosis Motor Neuron Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role collaborator

Ospedale San Raffaele

OTHER

Sponsor Role collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ospedale San Raffaele

Milan, MI, Italy

Site Status RECRUITING

Ospedale San Luca

Milan, MI, Italy

Site Status RECRUITING

AOU Città della Salute e della Scienza

Torino, TO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Nicola Ticozzi, MD, PhD

Role: CONTACT

+390261911 ext. 2937

Facility Contacts

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Yuri Falzone, MD, PhD

Role: primary

Alberto Doretti, MD

Role: primary

+0261911 ext. 2937

Adriano Chiò, MD

Role: primary

Other Identifiers

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23M202

Identifier Type: -

Identifier Source: org_study_id

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