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临床试验/NCT04315038
NCT04315038已完成不适用

Metabolomics Profiling and Biomarker Research of Human Cerebrospinal Fluid in Aging Process and Age-related Neurodegenerative Diseases

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2019年8月1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
190
试验地点
1
主要终点
Exam metabolic profiles of CSF in aging process and age-related neurodegenerative diseases

研究概览

简要总结

Perform quantitative metabolomics on human cerebrospinal fluid (CSF) samples and establish the first human CSF Metabolome Database of aging process in Taiwan.

详细描述

Metabolomics is new science based on metabolite profiles in biofluids and tissues, which under bioinformatics approaches and analyses could help to characterize metabolomic status of CSF in aging process. In this prospective study, the investigators plan to enroll 200 health volunteers and 40 neurodegenerative diseases patients with received operation under spinal anesthesia. Blood and CSF samples will be analyzed using hydrogen-1 nuclear magnetic resonance (1H-NMR) and lipid chromatography-mass spectrometry (LC-MS).

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aging groups:
  • . Above 20 years.
  • . No history of central nerve system injury and neurologic illness
  • . Written informed consent from the patient
  • Aged-related neurodegenerative diseases group:
  • . Above 60 years of age
  • . Medical record proved the history of Parkinsonism or Alzheimer disease
  • . Written informed consent from the patient or guardian by statute.

排除标准

  • patient refuses to sign informed consent
  • patients with coagulopathy, systemic infective disease and severe liver and renal function impairment
  • patients with spine or brain tumor and CNS disease
  • the presence of severe and/or uncontrolled and/or unstable medical disease within 12 months prior to study (e.g. acute pancreatitis, stroke, liver cirrhosis, congestive heart failure, and systemic immune disorder etc
  • Concurrent participation or planning to participate in another interventional clinical trial (Concurrent participation in an observational trial allowed)

结局指标

主要结局

Exam metabolic profiles of CSF in aging process and age-related neurodegenerative diseases

时间窗: An average of 1 year

Metabolites analysis of CSF will be investigated by NMR, LC-MS. Peak lists of all NMR and LC/MS/MS spectra will be searched against the database through a web server for metabolomic data analysis and further establish the CSF Metabolome Database.

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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