跳至主要内容
临床试验/NCT01950910
NCT01950910终止不适用

Establishment of a Tissue Bank (Blood, CSF) for the Understanding of the Disease Progression and Early Diagnosis of Motor Neuron Disease (MND).

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 766 人开始时间: 2004年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
766
试验地点
1
主要终点
Levels of ALS biomarkers in CSF

研究概览

简要总结

Biomarkers are essential for the identification of disease states. There are no early diagnostic or prognostic markers for ALS. The purpose of this study is to identify a panel of biomarkers from blood or spinal fluid of ALS patients and to collect data to better understand disease progression.

详细描述

Amyotrophic lateral sclerosis (ALS) is a motor neuron disease characterized by progressive degeneration of motor neurons, muscle atrophy and paralysis. There is no reliable early diagnostic test for ALS making identification of the disease difficult at its earliest stages. Early detection is critical to the initiation of early neuroprotective therapy. By the time a reliable diagnosis can be made, substantial damage to motor neurons and muscle has already occurred. The purpose of the current project is to establish a bank of blood samples (serum and protein/RNA/DNA from blood cells) and CSF for use in the development of an early diagnostic test for ALS and to better understand the progression of this disease.

Samples from patients that have a confirmed or unknown diagnosis of motor neuron disease will be examined. ALS and suspected neuromuscular disease (control) samples will be collected for comparison. Investigators will examine various biochemical, metabolic and genetic markers from these samples in hopes of finding differences in the expression between control subjects and ALS patients and how these biomarkers vary during disease progression. Participants will be asked to complete an optional questionnaire to collect data including medication and vitamin use and medical and disease history. This data will be linked to the patient's samples; however, all samples will be deidentified and coded to avoid the possibility of linking results to the patient. Results will not be stored in the patient's medical record.

研究设计

研究类型
Observational
观察模型
Other
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

  • 18 years old or older

排除标准

  • less than 18 years old

结局指标

主要结局

Levels of ALS biomarkers in CSF

时间窗: After CSF is collected from study subject. Data will be analyzed at one year.

CSF samples will be processed and assayed for biomarkers of interest. An aliquot of CSF sample will be stored for future study.

Levels of ALS biomarkers in blood

时间窗: After blood is collected from study subjects. Data will be analyzed at one year.

Blood samples will be processed to obtain serum samples and to isolate peripheral blood mononuclear cells (PBMC's). Serum samples will be analyzed for biochemical and metabolic markers of interest and future cell culture as needed. PBMCs will be processed for RNA, DNA or protein isolation. Aliquots of all samples will be stored for future study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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