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临床试验/NCT03316404
NCT03316404已完成不适用

Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response

DxTerity Diagnostics1 个研究点 分布在 1 个国家目标入组 1,168 人开始时间: 2017年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,168
试验地点
1
主要终点
Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS)

研究概览

简要总结

To develop a test to characterize and monitor Multiple Sclerosis (MS) disease status and therapy response from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.

详细描述

Multiple Sclerosis (MS) is an autoimmune disease that damages the central nervous system (CNS) and disrupts communication to and from the brain by attacking the myelin sheath surrounding neurons. It impairs control of bodily functions and leads to clinical disability as the disease progresses. The worldwide population is estimated at 2.5 million. MS typically develops in young adults; primarily women in their early 30s. The etiology of MS is not fully understood, but it is noted that the prevalence of MS differs with geography and ethnicity.

Biomarker signature panels are important tools for monitoring treatment response and screening for individuals who are unlikely to benefit from certain therapies. To establish a baseline and further characterize gene expression in MS, blood samples from individuals with MS will be collected. A rapid blood test to predict a treatment response would be an innovative diagnostic product that could aid in identifying individuals that may benefit from the targeted therapy. In the long term, such a test could bring significant clinical benefits by enabling individualized treatment to better control the disease, unburdening healthcare costs, and dramatically improving the management of MS.

In order to analyze gene expression data from individuals diagnosed with MS, the study will collect blood samples and information from up to 1500 subjects for analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Male and female patients age 18 or older
  • Have a permanent address in the United States for the duration of the study
  • Have an email address and access to the internet for the duration of the study
  • Able to provide informed consent
  • Self-reported diagnosis of MS

排除标准

  • 未提供

结局指标

主要结局

Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS)

时间窗: 2 years

Obtain blood samples and associated clinical and demographic data from participants diagnosed with Multiple Sclerosis (MS) to develop a blood test to characterize MS status by analyzing gene expression from blood samples.

次要结局

未报告次要终点

研究者

发起方
DxTerity Diagnostics
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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