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中国非小细胞肺癌患者外周血外泌体miRNAs作为早诊生物标志物的前瞻性研究
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注册号:

Registration number:

ChiCTR1800019877 

最近更新日期:

Date of Last Refreshed on:

2018-12-05 

注册时间:

Date of Registration:

2018-12-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国非小细胞肺癌患者外周血外泌体miRNAs作为早诊生物标志物的前瞻性研究 

Public title:

An prospective study for the early diagnosis of non-small-cell lung cancer by peripheral blood exosomal miRNAs biomarker detection 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国非小细胞肺癌患者外周血外泌体miRNAs作为早诊生物标志物的前瞻性研究 

Scientific title:

An prospective study for the early diagnosis of non-small-cell lung cancer by peripheral blood exosomal miRNAs biomarker detection 

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:

郑迪 

研究负责人:

郑迪 

Applicant:

Di Zheng 

Study leader:

Di Zheng 

申请注册联系人电话:

Applicant telephone:

+86 13801683953 

研究负责人电话:

Study leader's telephone:

+86 13801683953 

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:

zhengdiok@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

zhengdiok@hotmail.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:

上海市杨浦区政民路507号 

研究负责人通讯地址:

上海市杨浦区政民路507号 

Applicant address:

507 Zhengmin Road, Shanghai, China 

Study leader's address:

507 Zhengmin Road, Shanghai, 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:

上海市肺科医院 

Applicant's institution:

Shanghai Pulmonary 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:

K18-199Y 

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:

上海市肺科医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Shanghai pulmonary hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-30 

伦理委员会联系人:

桂涛 

Contact Name of the ethic committee:

Tao Gui 

伦理委员会联系地址:

上海市肺科医院 

Contact Address of the ethic committee:

Shanghai Pulmonary Hospital Tongji University School of Medicine, 507 Zhengmin Road, Shanghai, 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:

上海市肺科医院 

Primary sponsor:

Shanghai Pulmonary Hospital 

研究实施负责(组长)单位地址:

上海市杨浦区政民路507号 

Primary sponsor's address:

507 Zhengmin Road, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市肺科医院

具体地址:

上海市杨浦区政民路507号

Institution
hospital:

Shanghai Pulmonary Hospital

Address:

No.507 Zhengmin Road, Shanghai

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

非小细胞肺癌 

Target disease:

Non small cell 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:

基础科学研究 

Study phase:

Basic Science 

研究目的:

鉴定能够区分腺癌(AC)和良性肿瘤的外体microRNA生物标志物作为早期诊断非小细胞肺癌的非侵袭性方法。 

Objectives of Study:

To identify exosomal microRNAs that are able to discriminate between adenocarcinoma (AC) and benign tumors as a non-invasive method in the early diagnosis of non-small-cell 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:

队列研究 

Study design:

Cohort study 

纳入标准:

①胸部CT检测提示肺部结节病灶。 ②拟进行肺部结节病灶手术切除。 

Inclusion criteria

1. Chest CT examination suggests a pulmonary nodule lesion; 2. It is planned to perform surgical resection of pulmonary nodule lesions. 

排除标准:

①目前正在参加其他的临床研究。 ②任何精神病或认知障碍,从而限制受试者对知情同意书的理解和签署。 ③不能按照临床研究要求和方案的要求,参与临床研究。 ④曾经或现在已明确患有恶性肿瘤疾病。 

Exclusion criteria:

1. Currently participating in other clinical studies; 2. Any mental illness or cognitive impairment that limits the subject's understanding and signature of the informed consent form; 3. Can not participate in clinical research according to the requirements of clinical research requirements and programs; 4. It has been or is now clearly diagnosed with a malignant tumor. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2019-01-01To 2020-09-30 

干预措施:

Interventions:

组别:

肺腺癌

样本量:

40

Group:

adenocarcinoma (AC)

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

组别:

良性肿瘤

样本量:

40

Group:

benign tumors

Sample size:

干预措施:

外泌体miRNA测序

干预措施代码:

Intervention:

exosomal microRNAs sequencing

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市肺科医院 

单位级别:

三级甲等 

Institution
hospital:

上海市肺科医院  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

外泌体miRNA图谱

指标类型:

主要指标 

Outcome:

Exomal miRNA profiling

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:

Sample Name:

peripheral 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 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:

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

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):

原始数据公开于中国临床试验注册中Resman(http://www.medresman.org)

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

The original data will public on website within six months after the trial complete: Resman(http://www.medresman.org)

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:

采用SPSS数据库和Excel等保存原始数据

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

use SPSS database and Excel etc. to save the original data

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:

 2018-12-05
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