肝癌浸润天然免疫细胞的功能机制研究

注册号:

Registration number:

ChiCTR1900020787 

最近更新日期:

Date of Last Refreshed on:

2019-01-19 16:15:59 

注册时间:

Date of Registration:

2019-01-19 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

肝癌浸润天然免疫细胞的功能机制研究

Public title:

Functional mechanism of liver cancer infiltrating natural immune cells

注册题目简写:

English Acronym:

研究课题的正式科学名称:

肝癌浸润天然免疫细胞的功能机制研究

Scientific title:

Functional mechanism of liver cancer infiltrating natural immune cells

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:

刘欢 

研究负责人:

孙成 

Applicant:

Liu Huan 

Study leader:

Sun Cheng 

申请注册联系人电话:

Applicant telephone:

+86 17805650860

研究负责人电话:

Study leader's
telephone:

+86 13956074139

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:

lh94@mail.ustc.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

charless@ustc.edu.cn

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:

安徽省合肥市金寨路 96 号

研究负责人通讯地址:

合肥市庐阳区庐江路17号

Applicant address:

96 Jinzhai Road, Hefei, Anhui, China

Study leader's address:

17 Lujiang Road, Luyang District, Hefei, Anhui, China

申请注册联系人邮政编码:

Applicant postcode:

230026

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

中国科学技术大学

Applicant's institution:

University of Science and Technology of China

研究负责人所在单位:

中国科学技术大学

Affiliation of the Leader:

University of Science and Technology of China

是否获伦理委员会批准:

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 00:00:00

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:

中国科学技术大学第一附属医院

Primary sponsor:

The First Affiliated Hospital of University of Science and Technology of China

研究实施负责(组长)单位地址:

合肥市庐阳区庐江路17号

Primary sponsor's address:

17 Lujiang Road, Luyang District, Hefei, Anhui, 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):

安徽

市(区县):

Country:

China

Province:

Anhui

City:

单位(医院):

中国科学技术大学

具体地址:

安徽省合肥市金寨路 96 号

Institution
hospital:

university of science and technology of China

Address:

96 Jinzhai Road, Hefei, Anhui, China

经费或物资来源:

课题组资金

Source(s) of funding:

fund of the research group

研究疾病:

肝细胞癌  

Target disease:

HCC

研究疾病代码:

Target disease code:

研究类型:

病因学/相关因素研究

Study type:

Cause/Relative factors study

研究所处阶段:

基础科学研究 

Study phase:

Basic Science

研究设计:

单臂 

Study design:

Single arm 

研究目的:

探究肿瘤微环境对天然淋巴细胞的影响  

Objectives of Study:

To investigate the effect of tumor microenvironment on natural lymphocytes

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

丙型肝炎病毒感染、药物性、自身免疫性、血吸虫性、代谢性及其它原因肝硬化;
其他部位肿瘤及肝脏转移;
肝占位病变未确诊为 HCC 的病例。

Exclusion criteria:

Hepatitis c virus infection, drug, autoimmune, schistosomiasis, metabolic and other causes of liver cirrhosis;
Other tumors and liver metastases;
Hepatic space-occupying lesions were undiagnosed as HCC cases.

研究实施时间:

Study execute time:

From 2018-02-26 00:00:00 To 2022-06-15 00:00:00  

征募观察对象时间:

Recruiting time:

From 2019-02-16 00:00:00 To 2022-06-15 00:00:00

干预措施:

Interventions:

组别:

Case series

样本量:

100

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

安徽 

市(区县):

 

Country:

China

Province:

Anhui

City:

单位(医院):

中国科学技术大学 

单位级别:

大学 

Institution
hospital:

University of Science and Technology of China

Level of the institution:

University

国家:

中国

省(直辖市):

安徽 

市(区县):

 

Country:

China

Province:

Anhui

City:

单位(医院):

中国科学技术大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of university of science and Technology of China

Level of the institution:

Tertiary A Hospital

测量指标:

Outcomes:

指标中文名:

血清HBsAg定量

指标类型:

主要指标

Outcome:

serum HBsAg quantitation

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乙肝病毒DNA定量

指标类型:

主要指标

Outcome:

HBV DNA quantitation

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫细胞表型及功能变化

指标类型:

主要指标

Outcome:

phenotype and function change of immunocyte

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:

外周血

组织:

肝癌

Sample Name:

peripheral blood

Tissue:

tumor tisssues

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:

正在进行

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

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

相关论文被杂志接受后在GEO数据库上公布

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

The papers were accepted by the journal and published in the GEO database

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:

纸质版由实验负责人保存;电子版采用EXCEL格式进行保存。

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

The paper version materials was preserved by experimental operator, and the electronic version records was saved by using EXCEL software.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-19 16:15:59