Circulating Biomarker for Amyotrophic Lateral Sclerosis (ALS)
|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: NCT03088839|
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : January 31, 2019
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)|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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, 2019|
|Estimated Study Completion Date :||December 1, 2019|
|30 ALS patients|
|30 healthy controls|
- 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
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
|Contact: Alba Di Pardo||+39 0865 email@example.com|
|Contact: Alba Di Pardo|