- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03088839
Circulating Biomarker for Amyotrophic Lateral Sclerosis (ALS)
Observational Case-Control Study to Identify Circulating miR-218 as a Possible Non-invasive Biomarker of Amyotrophic Lateral Sclerosis (ALS)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Alba Di Pardo
- Phone Number: +39 0865 915212
- Email: dipardoa@hotmail.com
Study Locations
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Pozzilli, Italy
- Recruiting
- IRCCS Neuromed
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Contact:
- Alba Di Pardo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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30 ALS patients
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30 healthy controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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8 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADP_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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