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EGFR通过磷酸化RAB7A介导代谢重编程调控巨噬细胞极化在脓毒症中的作用及分子机制研究
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注册号:

Registration number:

ChiCTR2000039545 

最近更新日期:

Date of Last Refreshed on:

2020-10-31 

注册时间:

Date of Registration:

2020-10-31 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

EGFR通过磷酸化RAB7A介导代谢重编程调控巨噬细胞极化在脓毒症中的作用及分子机制研究 

Public title:

EGFR regulates macrophage polarization by phosphorylating Rab7A-mediated metabolic reprogramming Study on the role and molecular mechanism of sepsis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

EGFR通过磷酸化RAB7A介导代谢重编程调控巨噬细胞极化在脓毒症中的作用及分子机制研究 

Scientific title:

EGFR regulates macrophage polarization by phosphorylating Rab7A-mediated metabolic reprogramming Study on the role and molecular mechanism of sepsis 

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:

陈翠平 

研究负责人:

唐靖 

Applicant:

chen cui ping 

Study leader:

Tang Jing 

申请注册联系人电话:

Applicant telephone:

13729016162 

研究负责人电话:

Study leader's telephone:

13189091282 

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:

271783511@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

tanglitangjing@126.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:

广东省湛江市人民大道南57号 

研究负责人通讯地址:

广东省湛江市人民大道南57号 

Applicant address:

57 Renmin Dadao South, Zhanjiang City, Guangdong Province, China 

Study leader's address:

57 Renmin Dadao South, Zhanjiang City, Guangdong Province, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

广东医科大学附属医院 

Applicant's institution:

Affiliated Hospital of Guangdong Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

PJ2020-077 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

广东医科大学附属医院机构审查伦理委员会 

Name of the ethic committee:

Review Ethics Committee of Affiliated Hospital of Guangdong Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

梁政 

Contact Name of the ethic committee:

liang zheng 

伦理委员会联系地址:

广东省湛江市人民大道南57号 

Contact Address of the ethic committee:

57 Renmin Dadao South, Zhanjiang City, Guangdong Province, China 

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:

广东医科大学附属医院 

Primary sponsor:

Affiliated Hospital of Guangdong Medical University 

研究实施负责(组长)单位地址:

广东省湛江市人民大道南57号 

Primary sponsor's address:

57 Renmin Dadao South, Zhanjiang City, Guangdong Province, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

Country:

CHINA

Province:

Guangdong province

City:

单位(医院):

广东医科大学附属医院

具体地址:

广东省湛江市人民大道南57号

Institution
hospital:

Affiliated Hospital of Guangdong Medical University

Address:

57 Renmin Dadao South, Zhanjiang City, Guangdong Province, China

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

脓毒症 

Target disease:

Sepsis 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

探讨EGFR膜定位在脓毒症巨噬细胞活化中的作用,以及调控EGFR膜定位的分子机制。 

Objectives of Study:

To investigate the role of EGFR membrane localization in the activation of sepsis macrophages and the molecular mechanism of regulating EGFR membrane localization. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

①患者或家属对研究知情同意并签署知情同意书 ②住院脓毒症患者 ③男女不限,年龄18周岁以上 ④无其他严重系统疾病的患者 

Inclusion criteria

①Patients or family members give informed consent to the study and sign the informed consent ②Hospitalized patients with sepsis ③No male or female, age 18 or above ④Patients without other serious systemic diseases 

排除标准:

①伴有严重心肝肾和造血系统疾病 ②合并恶性肿瘤患者 ③术前患有中枢神经系统和心理疾病 

Exclusion criteria:

①Accompanied by severe heart, liver, kidney and hematopoietic diseases ②Patients with complicated malignant tumor ③He had a central nervous system and mental illness before surgery 

研究实施时间:

Study execute time:

From2020-10-10To 2021-10-10 

征募观察对象时间:

Recruiting time:

From2020-11-10To 2022-11-10 

干预措施:

Interventions:

组别:

非脓毒症患者组和脓毒症患者组

样本量:

50

Group:

Group of patients with sepsis

Sample size:

干预措施:

抽取脓毒症患者的血液

干预措施代码:

Intervention:

Collect blood from patients with sepsis

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

 

Country:

China 

Province:

Guangdong province 

City:

 

单位(医院):

广东医科大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Guangdong Medical University  

Level of the institution:

top first-class hospital 

测量指标:

Outcomes:

指标中文名:

表皮生长因子

指标类型:

主要指标 

Outcome:

epidermal growth factor

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 80 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):

由护士采取真空取血法抽取脓毒症患者的血液

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

The blood of patients with sepsis is drawn by the nurse by vacuum.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

项目组根据研究就进程择期选择具体公开原始数据

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

According to the research process, the project team selects the specific release of the original data.

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:

研究者根据受试者的原始观察记录,将数据及时、完整、正确、清晰地输入病例报告表。录入采用相同的数据库系统双人双机录入,之后对数据库进行两遍比对。电子数据文件分类保存,并有多个备份保存于不同磁盘或记录介质上,妥善保存,禁止破坏。

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

According to the original observation records of the subjects, the researcher will input the data into the case report form timely, complete, correct and clear.The same database system was used for input, and then the database was compared twice.Electronic data files are stored separately and with multiple backups on different disks or recording media. They are properly stored and no damage is allowed.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-10-31
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