跳至主要内容
临床试验/NCT04300543
NCT04300543Unknown不适用

MicroRNA-150 and microRNA-155 as Molecular Biomarkers in Multiple Sclerosis

Assiut University0 个研究点目标入组 140 人开始时间: 2020年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
主要终点
Evaluate the serum levels of oligoclonal bands, neurofilaments and chitinase-3-like-1 in serum of MS patients

研究概览

简要总结

A study To analyse the expression of circulating miR-150 and miR-155 in serum of MS patients, Evaluate the serum levels of oligoclonal bands, neurofilaments and chitinase-3-like-1 in serum of MS patients, and Investigate the correlation between the measured biomarkers and each other and their correlation with different MS phenotypes , disability status and the patients demographic data.

详细描述

Multiple sclerosis (MS) is a chronic neurodegenerative autoimmune disease characterized by infiltration of immune cells into the central nervous system (CNS) with subsequent demyelination, axonal degeneration and neuronal death MS is the most common cause of non traumatic lifelong disability in young adults, affecting women almost three times as often as men

The incidence of MS is increasing worldwide, together with the socioeconomic impact of the disease There is no definite measure or laboratory marker for the diagnosis of MS yet In a patient presenting with an attack, the most important paraclinical test is magnetic resonance imaging (MRI) with intravenous (iv) contrast agent containing gadolinium. This can both present the nature of the lesions (inflammatory and demyelinating characteristics) for differential diagnosis, and the distribution of the lesions within the CNS (evidence of dissemination in time [DIT] and space [DIS] according to the latest McDonald Criteria (2017) Clinical and imaging findings that may be seen in MS, can also be mimicked by some infectious, neoplastic, genetic, metabolic, vascular and other idiopathic inflammatory demyelinating disorders (IIDD) Therefore, to identify MS-related attacks and determine the final diagnosis is vital for the correct treatment choice and longterm disability prevention.

The currently used biomarkers for diagnosing of MS include IgM and IgG antibodies , chemokines, glycoproteins and cell surface markers of inflammation . However, the disease course is very diverse and the heterogenesity in its phenotype not well correlated with biomarkers currently used thus, it is compulsory to identify new specific biomarkers that can help in distinguishing the different MS phenotypes , anticipate the progress of the disease and afford a correlate with the disability status

So, why are biomarkers for MS still arousing interest? Emerging biomarkers, such as circulating miRNAs, display several advantageous features in comparison with previous methods , The possibility to support the results of the clinical diagnosis distinguishing MS subtypes (PPMS, RRMS, etc.) and quantify MS severity , the fact that collecting blood miRNAs and measuring their expression is easy, poorly invasive, and cheap , the robustness of circulating miRNAs which are highly stable, and the accuracy using composite biomarkers rather than a single one.

MicroRNAs (miRNAs) are small non-coding RNA molecule (containing about 22 nucleotides) found in plants, animals and some viruses, that functions in RNA silencing and post-transcriptional regulation of gene expression.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed as MS (clinically and by imaging) according to revised 2017 McDonald Criteria .
  • Each patient will be subjected to complete medical history uptake including : Age, Sex, age at onset of the disease, phenotype of the disease and its duration, frequency of relapses and remissions , EDSS(The Expanded Disability Status Scale ) is a method of quantifying disability in multiple sclerosis) and MRI findings.

排除标准

  • Patients with non neurological autoimmune diseases, malignancy, cardiac and renal diseases that can affect level of miRNAs .

结局指标

主要结局

Evaluate the serum levels of oligoclonal bands, neurofilaments and chitinase-3-like-1 in serum of MS patients

时间窗: baseline

measure the levels of OCB, NF-L and NF-H , and CHI3L1 in different MS phenotypes

analyse the expression of circulating miR-150 and miR-155 in serum of MS patients

时间窗: baseline

to measure the levels of miR-150 and miR-155 in different MS phenotypes

次要结局

  • Investigate the correlation between the measured biomarkers and each other and their correlation with different MS phenotypes , disability status and the patients demographic data(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lamia Ahmed

Administrator

Assiut University

相似试验