Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry

NCT ID: NCT07143656

Last Updated: 2025-08-28

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

ACTIVE_NOT_RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-13

Study Completion Date

2028-09-01

Brief Summary

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This retrospective observational study will analyze de-identified clinical data from patients with amyotrophic lateral sclerosis (ALS) collected at multiple centers over 7 years. The primary objective is to describe disease progression using the ALS Functional Rating Scale-Revised (ALSFRS-R). Secondary objectives include evaluating survival, ventilatory decline, and correlations between available biomarkers (e.g., neurofilament light chain, cytokines) and disease trajectory. No new interventions or patient contact will occur.

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Imaging and Clinical Reports

Inclusion of existing imaging data (MRI, EMG reports) and standard clinical documentation, where available.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of amyotrophic lateral sclerosis (ALS) or motor neuron disease confirmed.
2. Age ≥18 years.
3. Availability of at least one ALS Functional Rating Scale-Revised (ALSFRS-R) score.
4. Availability of longitudinal follow-up data.

Exclusion Criteria

1. Patients with alternative diagnoses that mimic ALS (e.g., multifocal motor neuropathy, cervical myelopathy, myasthenia gravis).
2. Absence of medical records
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biocells Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Biocells Medical

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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Bio120003

Identifier Type: -

Identifier Source: org_study_id

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