Today is 2019-12-08

Clinical study for predicting therapeutic effect of free circulating DNA in lung cancer radiotherapy
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注册号:

Registration number:

ChiCTR1900027590 

最近更新日期:

Date of Last Refreshed on:

2019-11-20 

注册时间:

Date of Registration:

2019-11-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

游离循环DNA预测肺癌放疗疗效的临床研究 

Public title:

Clinical study for predicting therapeutic effect of free circulating DNA in lung cancer radiotherapy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

游离循环DNA预测肺癌放疗疗效的临床研究 

Scientific title:

Clinical study for predicting therapeutic effect of free circulating DNA in lung cancer radiotherapy 

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:

张金岭 

研究负责人:

张金岭 

Applicant:

Zhangjinling 

Study leader:

Zhangjinling 

申请注册联系人电话:

Applicant telephone:

+86 0539-8071229 

研究负责人电话:

Study leader's telephone:

+86 0539-8071229 

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:

lysrmyykyk@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lysrmyykyk@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:

山东省临沂市解放路东段27号 

研究负责人通讯地址:

山东省临沂市解放路东段27号 

Applicant address:

27 East Section of Jiefang Road, Linyi, Shandong, China 

Study leader's address:

27 East Section of Jiefang Road, Linyi, Shandong, 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:

临沂市人民医院 

Applicant's institution:

Linyi City People's Hospital 

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:

20031 

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:

临沂市人民医院伦理委员会 

Name of the ethic committee:

Linyi City People's Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

肖帅 

Contact Name of the ethic committee:

Xiao Shuai 

伦理委员会联系地址:

山东省临沂市解放路东段27号 

Contact Address of the ethic committee:

27 East Section of Jiefang Road, Linyi, Shandong, 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:

临沂市人民医院 

Primary sponsor:

Linyi City People's Hospital 

研究实施负责(组长)单位地址:

山东省临沂市解放路东段27号 

Primary sponsor's address:

27 East Section of Jiefang Road, Linyi, Shandong, 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):

山东

市(区县):

临沂

Country:

China

Province:

Shandong

City:

Linyi

单位(医院):

临沂市人民医院

具体地址:

解放路东段27号

Institution
hospital:

Linyi City People's Hospital

Address:

27 East Section of Jiefang Road

经费或物资来源:

临沂市科技局 

Source(s) of funding:

Linyi City Science and Technology Bureau 

研究疾病:

肺癌 

Target disease:

lung cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

1.检测肺癌患者放疗前、后外周血中循环游离DNA的变化; 2.分析该变化特征与肿瘤反应和患者预后的关系,寻找敏感的预后指标; 3.根据准确预测肺癌疗效的循环游离DNA变化,指导临床放疗。 

Objectives of Study:

Research guidance lung cancer individualized radiotherapy. 

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:

近三个月内诊断为肺癌的患者,不限制病理类型,且未接受放射治疗。 

Inclusion criteria

Patients diagnosed with lung cancer in the past three months do not limit the type of pathology. 

排除标准:

已受放疗的患者,放疗中断治疗的患者,放疗同时接受化疗以外治疗方式的患者。 

Exclusion criteria:

Patients who have not received radiotherapy, patients who have interrupted radiotherapy, and patients who have received radiotherapy in addition to chemotherapy. 

研究实施时间:

Study execute time:

From2019-12-01To 2021-06-01 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcome

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

循环游离DNA

Index test:

Free circulating DNA

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

未接受放射治疗的肺癌患者

例数:

Sample size:

100

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Untreated lung cancer patients

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

临沂 

Country:

China 

Province:

Shandong 

City:

Linyi 

单位(医院):

临沂市人民医院 

单位级别:

三甲 

Institution
hospital:

Linyi City People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

游离循环DNA浓度

指标类型:

主要指标 

Outcome:

Free circulating DNA concentration

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

游离循环DNA形态特征

指标类型:

次要指标 

Outcome:

Morphological characteristics of free circulating DNA

Type:

Secondary 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:

Sample Name:

Peripheral 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 20 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):

N/A

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

N/A

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

百度网盘

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

Baidu Network Disk

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:

EDC基于的CRF

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

EDC based CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-20
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