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EGFR敏感突变NSCLC脑转移TKI治疗联合SRS治疗时机引起放射性脑坏死差异:基于病历记录的回顾性研究
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注册号:

Registration number:

ChiCTR1900022750 

最近更新日期:

Date of Last Refreshed on:

2019-04-24 

注册时间:

Date of Registration:

2019-04-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

EGFR敏感突变NSCLC脑转移TKI治疗联合SRS治疗时机引起放射性脑坏死差异:基于病历记录的回顾性研究 

Public title:

Management of brain metastases in tyrosine kinase inhibitor-naive epidermal growth factor receptor-mutant non-small-cell lung cancer from the perspective of long-term radiation brain damage: a case records based retrospective study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

EGFR敏感突变NSCLC脑转移TKI治疗联合SRS治疗时机引起放射性脑坏死差异:基于病历记录的回顾性研究 

Scientific title:

Management of brain metastases in tyrosine kinase inhibitor-naive epidermal growth factor receptor-mutant non-small-cell lung cancer from the perspective of long-term radiation brain damage: a case records based retrospective study 

研究课题代号(代码):

Study subject ID:

北京大学第三医院临床重点项目课题 编号: BYSY2017030 

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:

庄洪卿 

研究负责人:

庄洪卿 

Applicant:

Zhuang Hongqing 

Study leader:

Zhuang Hongqing 

申请注册联系人电话:

Applicant telephone:

+86 13051776232 

研究负责人电话:

Study leader's telephone:

+86 13051776232 

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:

yiduzhengmu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yiduzhengmu@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:

北京市海淀区花园北路49号 

研究负责人通讯地址:

北京市海淀区花园北路49号 

Applicant address:

49 Huayuan Road North, Haidian District, Beijing, China 

Study leader's address:

49 Huayuan Road North, Haidian District, Beijing, 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:

北京大学第三医院 

Applicant's institution:

Peking University Third Hospital 

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:

北京大学第三医院 

Primary sponsor:

Peking University Third Hospital 

研究实施负责(组长)单位地址:

北京市海淀区花园北路49号 

Primary sponsor's address:

49 Huayuan Road North, Haidian District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学第三医院

具体地址:

北京市海淀区花园北路49号

Institution
hospital:

Peking University Third Hospital

Address:

49 Huayuan Road North, Haidian District, Beijing, China

经费或物资来源:

北京大学第三医院临床重点项目课题 编号: BYSY2017030 

Source(s) of funding:

The key clinical specialist research fund of Peking University Third Hospital 

研究疾病:

肺癌 

Target disease:

Lung cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

探讨EGFR敏感突变NSCLC脑转移TKI治疗时SRS介入时机与放射性脑坏死并发症的关系以及对患者生存质量的影响。 

Objectives of Study:

To investigate the relationship between the timing of SRS intervention and the complications of cerebral radiation necrosis(CRN) and its impact on the cognitive function and quality of life(QOL) in patients with brain metastases of lung adenocarcinoma who received TKI treatment. 

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:

①NSCLC颅内转移(转移灶≦4个);②EGFR19或EGFR21突变;③颅内转移灶行SRS或者全脑放疗加SRS治疗;④SRS后随访时间大于10个月; 

Inclusion criteria

1. Patients with brain primary or metastatic tumors; 2. SRS history of intracranial lesions; 3. Pathological puncture or imaging diagnosis of brain radiation necrosis. 

排除标准:

①未发生脑坏死患者立体定向放疗后随访时间小于10m;②SRS后局部病灶进行手术不能进一步判定局部病灶性质患者。 

Exclusion criteria:

1. the follow-up time was <10 months for patients with no brain necrosis after stereotactic radiotherapy; 2. the local lesions could not be further characterized during their surgery after SRS. 

研究实施时间:

Study execute time:

From2019-04-24To 2019-06-28 

干预措施:

Interventions:

组别:

1Case group versus control group

样本量:

200

Group:

Case group versus control group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第三医院 

单位级别:

三甲医院 

Institution
hospital:

Peking University Third Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

放射性脑损伤

指标类型:

主要指标 

Outcome:

CRN

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:

组织:

Sample Name:

None

Tissue:

None

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):

无随机

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

None

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):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

网络平台

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

web-based public 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:

Case Record Form, CRF

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-24
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