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晚期肺癌精准内科治疗伞形研究
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注册号:

Registration number:

ChiCTR1900027582 

最近更新日期:

Date of Last Refreshed on:

2019-11-23 

注册时间:

Date of Registration:

2019-11-19 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

晚期肺癌精准内科治疗伞形研究 

Public title:

Umbrella study of precise medical treatment in advanced lung cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

晚期肺癌精准内科治疗伞形研究 

Scientific title:

Umbrella study of precise medical treatment in advanced lung cancer 

研究课题代号(代码):

Study subject ID:

2016YFC0905500, 2016YFC0905503 

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:

张仲翰 

研究负责人:

张力 

Applicant:

Zhang Zhonghan 

Study leader:

Zhang Li 

申请注册联系人电话:

Applicant telephone:

+86 020 87343786 

研究负责人电话:

Study leader's telephone:

+86 020 87343822 

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:

zhangzhongh@sysucc.org.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhangli@sysucc.org.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:

中国广东省广州市东风东路651号 

研究负责人通讯地址:

中国广东省广州市东风东路651号 

Applicant address:

651 Dongfeng Road East, Guangzhou, Guangdong, China 

Study leader's address:

651 Dongfeng Road East, Guangzhou, Guangdong, 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:

中山大学肿瘤防治中心 

Applicant's institution:

Sun Yat-Sen University Cancer Center  

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:

GZJZ-SB2016-010 

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:

中山大学肿瘤防治中心伦理委员会 

Name of the ethic committee:

Sun Yat-Sen University Cancer Center Institution Review Board  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-05-18 

伦理委员会联系人:

潘旭芝 

Contact Name of the ethic committee:

Pan Xuzhi 

伦理委员会联系地址:

中国广东省广州市东风东路651号 

Contact Address of the ethic committee:

651 Dongfeng Road East, Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 20 87343009 

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:

中山大学肿瘤防治中心 

Primary sponsor:

Sun Yat-Sen University Cancer Center  

研究实施负责(组长)单位地址:

中国广东省广州市东风东路651号 

Primary sponsor's address:

651 Dongfeng Road East, Guangzhou, Guangdong, 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

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学肿瘤防治中心

具体地址:

中国广东省广州市东风东路651号

Institution
hospital:

Sun Yat-Sen University Cancer Center

Address:

651 Dongfeng Road East, Guangzhou, Guangdong, China

经费或物资来源:

中山大学肿瘤防治中心 

Source(s) of funding:

Sun Yat-Sen University Cancer Center  

研究疾病:

肺癌 

Target disease:

Lung cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

利用多基因二代测序技术,根据驱动基因变异开展大型前瞻性临床研究,探讨少见驱动基因肺癌治疗规范,抑制耐药发生策略以及无驱动基因肺癌治疗新方案。 

Objectives of Study:

By using the next-generation genomic sequencing technology, lung cancer patients were allocated to different large-scale prospective clinical trials according to the genomic testing results. To explore the new treatment standard for rare driver gene of lung cancer, the strategy for delaying resistance of lung cancer with classic driver gene and the new treatment regimens for no driver gene of lung cancer. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.组织学确诊的转移性肺癌; 2. 有足够的标本(血液/组织)用于二代测序多基因检测;或有可供测序的肿瘤冰冻组织或其他生物标本; 3.签署知情同意书。 4.有完整的临床资料。  

Inclusion criteria

1. Pathologically confirmed metastastic lung cancer; 2. With available sample(blood/tisse) for NGS genetic testing; or available freezing tumor tissue or other biological sample for genetic testing; 3. Signed the informed consent form; 4. With complete clinical information.  

排除标准:

没有可供测序的肿瘤冰冻组织或其他生物标本。 

Exclusion criteria:

Without available sample(blood/tisse) for NGS genetic testing; or unavailable freezing tumor tissue or other biological sample for genetic testing. 

研究实施时间:

Study execute time:

From2016-05-18To 2020-03-31 

征募观察对象时间:

Recruiting time:

From2016-05-18To 2020-03-31 

干预措施:

Interventions:

组别:

Case series

样本量:

1000

Group:

Case series

Sample size:

干预措施:

不适用

干预措施代码:

Intervention:

Not applicable

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学肿瘤防治中心 

单位级别:

三甲医院 

Institution
hospital:

Sun Yat-Sen University Cancer Center  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

总生存期

指标类型:

主要指标 

Outcome:

Overall survival

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:

肺及其他转移器官

Sample Name:

Blood

Tissue:

lung and metastastic lesion

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 90 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):

不适用

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

Not applicable.

盲法:

N/A

Blinding:

N/A

是否共享原始数据:

IPD sharing

是Yes

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):

网络平台 网址:www.chictr.org.cn/

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

web-based public database: www.chictr.org.cn/

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:

数据采集:病例记录表; 数据管理:Excel 和 SPSS 22.0版本。

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

Data collection: Case Record Form; Data management: Excel and SPSS version 22.0.

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:

 2019-11-19
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