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Circulating Biomarker for Amyotrophic Lateral Sclerosis (ALS)

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ClinicalTrials.gov Identifier: NCT03088839
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : May 19, 2022
Information provided by (Responsible Party):
Alba Di Pardo, Neuromed IRCCS

Brief Summary:

Amyotrophic Lateral Sclerosis (ALS) is a rare disease with a worldwide incidence of 2-3 cases per 100,000 individuals/year and it is characterized by progressive neurodegeneration of motor neurons. When motor neurons degenerate the ability of the brain to initiate and control muscle movement is lost. ALS manifests in two forms: Familiar ALS (FALS) with inherited risk genotypes, accounts for only 10% of cases and sporadic ALS (SALS) without apparent heritability accounts for 90% of cases. ALS can occur in both female and male subjects at any age but is more common in people aged over 40.

Although the molecular mechanism underlying the pathogenesis of ALS is still under investigation, recent research has revealed that diseases affecting motor neurons may be associated to alterations of RNA metabolism and biogenesis of small non-coding micro RNAs (miRNAs). miRNAs are circulating molecules, whose expression profiles are widely described to have an important potential in monitoring the progression of a disease, to promote the development of more targeted therapies and/or to determine the effectiveness of treatments. Altered patterns of specific miRNAs expression have been described in several pathological conditions. Evidence shows a significant reduction in the levels of certain miRNAs also in patients with ALS. Among others, miRNA-218 has been described to play a critical role in the onset of motor neurons differentiation and in establishing cell identity and fate.

Changes in the levels of miRNA-218 in the serum of ALS patients may potentially provide useful tools to determine the possible association with this disease and to candidate it as indicator of disease progression.

Condition or disease
Amyotrophic Lateral Sclerosis (ALS)

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Observational Case-Control Study to Identify Circulating miR-218 as a Possible Non-invasive Biomarker of Amyotrophic Lateral Sclerosis (ALS)
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 1, 2024

30 ALS patients
30 healthy controls

Primary Outcome Measures :
  1. Identification of circulating miR-218 as biomarker for ALS [ Time Frame: 8 months ]
    Quantitative assessment of potential changes in the levels of miR-218 in the serum of ALS patients vs healthy controls

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
A total of 60 individuals (30 subjects clinically diagnosed as ALS patients and 30 healthy controls) will be recruited at Centre for Rare Diseases, IRCCS Neuromed

Inclusion Criteria:

  • ALS patients admitted to Centre for Rare Diseases, IRCCS Neuromed,
  • Patients diagnosed ALS within 6 months,
  • Patients age between 20 years and 75 years old,
  • Patients underwent to differential diagnosis using diagnostic tools (EMG, NCV, MRI) to exclude other diseases with similar signs and symptoms,
  • Subjects able to communicate verbally or by using a non-verbal communication system.

Exclusion Criteria:

  • Pregnant women,
  • Subjects with malignant tumor,
  • Subjects/Patients with others neurological or psychiatric disorders,
  • Subjects/Patients with systemic diseases,
  • Subjects/Patients with positive blood test for hepatitis B or C, or HIV,
  • Patients included in other clinical trials,
  • Subjects/Patients showing inability to understand the informed consent and the study's purpose

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088839

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Contact: Alba Di Pardo +39 0865 915212 dipardoa@hotmail.com

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IRCCS Neuromed Recruiting
Pozzilli, Italy
Contact: Alba Di Pardo         
Sponsors and Collaborators
Neuromed IRCCS
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Responsible Party: Alba Di Pardo, Dr., Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT03088839    
Other Study ID Numbers: ADP_01
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases