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Research of susceptibility genes of lung cancer
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注册号:

Registration number:

ChiCTR-RCC-12002830 

最近更新日期:

Date of Last Refreshed on:

2015-12-27 

注册时间:

Date of Registration:

2012-12-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肺癌易感基因相关性研究 

Public title:

Research of susceptibility genes of lung cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肺癌易感基因相关性研究 

Scientific title:

Research of susceptibility genes of lung cancer 

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:

王瑛 

研究负责人:

刘昭前 

Applicant:

Ying Wang 

Study leader:

Zhao-qian Liu 

申请注册联系人电话:

Applicant telephone:

+86 13973228877 

研究负责人电话:

Study leader's telephone:

+86 13787797720 

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:

wy552@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

liuzhaoqian63@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:

湖南省长沙市开福区湘雅路110号中南大学临床药理研究所 

研究负责人通讯地址:

湖南省长沙市开福区湘雅路110号中南大学临床药理研究所 

Applicant address:

110 Xiangya Road, Changsha, Hunan, China 

Study leader's address:

110 Xiangya Road, Changsha, Hunan, 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:

中南大学临床药理研究所 

Applicant's institution:

Institute of Clinical Pharmacology, Central South 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:

CTXY-110008-3 

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:

中南大学临床药理所伦理委员会 

Name of the ethic committee:

Ethic Committee of Institute of Clinical Pharmacology, Central South University 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-07-13 

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:

中南大学临床药理研究所 

Primary sponsor:

Institute of Clinical Pharmacology, Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市开福区湘雅路110号中南大学临床药理研究所 

Primary sponsor's address:

110 Xiangya Road, Changsha, Hunan, 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):

湖南

市(区县):

Country:

China

Province:

Hunan

City:

单位(医院):

中南大学临床药理研究所

具体地址:

湖南省长沙市开福区湘雅路110号中南大学临床药理研究所

Institution
hospital:

Institute of Clinical Pharmacology, Central South University

Address:

110 Xiangya Road, Changsha, Hunan, China

经费或物资来源:

国家高技术研究发展计划(863 计划) 

Source(s) of funding:

The national high technology research and development program (863 Program) 

研究疾病:

肺癌 

Target disease:

Lung cancer 

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:

其它 

Study phase:

N/A 

研究目的:

寻找与肺癌易感性相关的新的基因,寻找新的肺癌相关的不同甲基化水平及差异表达基因 

Objectives of Study:

Looking for lung cancer related new genes which were associated with different methylation levels and differential expression. 

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:

经病理组织细胞学检查确诊为肺癌患者 

Inclusion criteria

lung cancer patients diagnosed by Histologically cytology 

排除标准:

非原发性肺癌 

Exclusion criteria:

Non-primary lung cancer 

研究实施时间:

Study execute time:

From2011-08-01To 2014-09-21 

征募观察对象时间:

Recruiting time:

From2011-08-01To 2014-09-21 

干预措施:

Interventions:

组别:

肺癌患者

样本量:

400

Group:

Lung cancer group

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

对照组

样本量:

4000

Group:

Control group

Sample size:

干预措施:

干预措施代码:

Intervention:

no

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

中南大学临床药理研究所 

单位级别:

遗传药理学湖南省重点实验室 

Institution
hospital:

Institute of Clinical Pharmacology, Central South University  

Level of the institution:

Hunan key laboratory of pharmacogenetics 

测量指标:

Outcomes:

指标中文名:

CT

指标类型:

主要指标 

Outcome:

CT

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

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 30 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):

NA

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

NA

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

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

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:

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

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:

 2012-12-17
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