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临床试验/NCT03611166
NCT03611166Unknown不适用

iTRAQ-Based Proteomics Reveals Potential Biomarkers for Chronic Disorder of Consciousness

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Protein profiling

研究概览

简要总结

Following severe traumatic brain injury, patients may remain unconscious for many years. It is the first proteomic analysis comparing differentially expressed proteins between patients with chronic disorder of consciousness and controls so far. The investigators generated accurate lists of proteomes and identified differences at different disease time courses. The obtained results provide new insight into understanding the molecular mechanisms underlying the chronic disorder of consciousness.

详细描述

Background: Patients who awake from severely traumatic brain injury (sTBI) may remain unconscious for many years. Although behavioral assessment and functional imaging are currently used as diagnostic tools, the molecular basis underlying chronic condition has yet to be explored.

Objective

To explore the molecular basis and identify novel biomarkers for the diagnosis and prognosis of patients with chronic disorder of consciousness.

Method: Plasma samples were obtained from patients with chronic disorder of consciousness, and healthy volunteers. A coupled isobaric tag for relative and absolute quantitation (iTRAQ)-based proteomics approach was used to screen differentially expressed proteins (DEPs) between patients and controls. Potential molecular mechanisms were further discussed through bioinformatics analyses. Candidate proteins were validated by enzyme-linked immunosorbent assay (ELISA).

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
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ages 14 to 65 years old;
  • Patients had a history of sTBI;
  • Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state;
  • Patients stay unconscious for more than 1 month.

排除标准

  • Patients with acute infectious diseases or liver dysfunction;
  • Patients with serious diseases such as cardiac or pulmonary problems.

结局指标

主要结局

Protein profiling

时间窗: Three months

A coupled isobaric tag for relative and absolute quantitation (iTRAQ)-based proteomics approach was used to screen differentially expressed proteins (DEPs) between patients and controls.

次要结局

  • Glasgow Outcome Scale (GOS)(In one year)
  • Coma Recovery Scale-Revised(CRS-R)(30 minutes before blood collection)

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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