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The correlation study of the serial expression of EZH2 on the immune cells of the septic patients with prognsis
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注册号:

Registration number:

ChiCTR1900027621 

最近更新日期:

Date of Last Refreshed on:

2019-11-21 

注册时间:

Date of Registration:

2019-11-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

李哲医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 外周血免疫细胞中EZH2动态改变与脓毒症患者病情进展及预后的相关性研究 

Public title:

The correlation study of the serial expression of EZH2 on the immune cells of the septic patients with prognsis  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

外周血免疫细胞中EZH2动态改变与脓毒症患者病情进展及预后的相关性研究 

Scientific title:

The correlation study of the serial expression of EZH2 on the immune cells of the septic patients with prognsis  

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

李哲 

研究负责人:

唐伦先 

Applicant:

Li Zhe 

Study leader:

Tang Lunxian 

申请注册联系人电话:

Applicant telephone:

+86 13262701953 

研究负责人电话:

Study leader's telephone:

+86 18916290981 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

13390577069@163.com 

研究负责人电子邮件:

Study leader's E-mail:

456tlx@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

上海市杨浦区赤峰路50号 

研究负责人通讯地址:

中国上海云台路1800号 

Applicant address:

50 Chifeng Road, Yangpu District, Shanghai 

Study leader's address:

1800 Yuntai Road, Shanghai, China. 

申请注册联系人邮政编码:

Applicant postcode:

200120 

研究负责人邮政编码:

Study leader's postcode:

200120 

申请人所在单位:

同济大学医学院 

Applicant's institution:

Medical School /Tongji University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

上海市东方医院 

Primary sponsor:

Shanghai East Hospital 

研究实施负责(组长)单位地址:

上海市浦东新区即墨路150号 

Primary sponsor's address:

150 Jimo Road, Pudong New Area, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市东方医院

具体地址:

浦东新区即墨路150号

Institution
hospital:

Shanghai East Hospital

Address:

150 Jimo Road, Pudong New Area

经费或物资来源:

国家自然科学基金;上海市浦东新区领先人才计划 

Source(s) of funding:

National Natural Science Foundation of China; Shanghai Pudong New Area Leading Talent Program 

研究疾病:

脓毒症 

Target disease:

sepsis 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

探索EZH2在脓毒症患者外周血免疫细胞中的动态表达与疾病进展及预后的关系。 

Objectives of Study:

To explore correlation of the expression levels of EZH2 on the immune cells with the prognosis of septic patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1、年龄:≥18岁; 2、就诊于东方医院的脓毒症病人:符合“脓毒症3.0定义”中关于脓毒症的定义,即脓毒症为机体感染反应失调而导致的危及生命的器官功能障碍; 3、对基础器官功能障碍状态未知或感染前已有器官功能障碍的患者,基线SOFA评分定为0分,将感染后SOFA评分≥2作为器官功能障碍的临床诊断标准; 4、知情同意。 

Inclusion criteria

1, age: >= 18 years; 2, a sepsis patient visiting the Shanghai East Hospital: in accordance with the definition of sepsis in "Sepsis 3.0", which is, sepsis is a life-threatening organ dysfunction caused by the imbalance of the host infection response 3. For patients with unknown organ dysfunction status or organ dysfunction before infection, the baseline SOFA score is set to 0, and the post-infection SOFA score >= 2 is used as the clinical diagnostic criteria for organ dysfunction. 4. Informed consent. 

排除标准:

1、急慢性炎症性疾病; 2、伴随其它疾病,如:肿瘤、肾脏疾病、自身免疫性疾病等; 3、目前正参加或一个月内曾参加其他临床试验; 4、过去5年中酒精或药物依赖; 5、患有精神疾病。 

Exclusion criteria:

1. Acute and chronic inflammatory diseases; 2. Along with other diseases, such as: tumors, kidney diseases, autoimmune diseases, etc.; 3. Currently participating in or participating in other clinical trials within one month; 4. Alcohol or drug dependence in the past 5 years; 5. Suffering from mental illness, can not achieve informed consent. 

研究实施时间:

Study execute time:

From2019-12-01To 2020-12-31 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcome

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

外周血免疫细胞中EZH2动态改变

Index test:

the serial expression of EZH2 on the immune cells

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

脓毒症患者

例数:

Sample size:

120

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients with sepsis.

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

健康对照人群

例数:

Sample size:

40

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Healthy people

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市东方医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai East Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

EZH2

指标类型:

主要指标 

Outcome:

EZH2

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 100 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

Randomization Procedure (please state who generates the random number sequence and by what method):

None

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

论文

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

article

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

CRF表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-21
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