Today is 2019-12-12

A retrospective serial registration study of pulmonary nodules
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注册号:

Registration number:

ChiCTR1900027641 

最近更新日期:

Date of Last Refreshed on:

2019-11-22 

注册时间:

Date of Registration:

2019-11-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肺结节系列病例回顾性注册研究 

Public title:

A retrospective serial registration study of pulmonary nodules 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肺结节系列病例回顾性注册研究 

Scientific title:

A retrospective serial registration study of pulmonary nodules 

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:

田博 

研究负责人:

李强 

Applicant:

Bo Tian 

Study leader:

Qiang Li 

申请注册联系人电话:

Applicant telephone:

+86 18980053101 

研究负责人电话:

Study leader's telephone:

+86 13708063611 

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:

dr.tianbo@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

liqiang@sichuancancer.org 

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:

成都市人民南路四段55号 

研究负责人通讯地址:

成都市人民南路四段55号 

Applicant address:

55 Section 4, South Renmin Road, Chengdu, Sichuan, China 

Study leader's address:

55 Section 4, South Renmin Road, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川省肿瘤医院 

Applicant's institution:

Sichuan Cancer 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:

SCCHEC-02-2019-019 

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:

四川省肿瘤医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Sichuan Cancer Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-29 

伦理委员会联系人:

郑靖 

Contact Name of the ethic committee:

Jing Zheng 

伦理委员会联系地址:

成都市人民南路四段55号 

Contact Address of the ethic committee:

55 Section 4, South Renmin Road, Chengdu, Sichuan, 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:

四川省肿瘤医院 

Primary sponsor:

Sichuan Cancer Hospital 

研究实施负责(组长)单位地址:

成都市人民南路四段55号 

Primary sponsor's address:

55 Section 4, South Renmin Road, Chengdu, Sichuan, 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):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川省肿瘤医院

具体地址:

成都市人民南路四段55号

Institution
hospital:

Sichuan Cancer Hospital

Address:

55 Section 4, South Renmin Road, Chengdu

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

肺结节 

Target disease:

Pulmonary nodules 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

拟对在我院已行肺结节手术的患者进行调查,了解中国人群中肺部小结节的现状,通过数据分析处理建立评估方法、随访策略,希望通过结节大小、形态学改变、肿瘤标志物、肿瘤相关基因等,建立良恶性判别模型,及时发现早期肺癌,争取最佳的治疗介入时机。 

Objectives of Study:

To investigate the patients who have undergone pulmonary nodule surgery in our hospital, understand the current situation of small pulmonary nodule in Chinese population, establish evaluation methods and follow-up strategies through data analysis and processing, hope to establish a benign and malignant discrimination model through nodule size, morphological changes, tumor markers, tumor related genes, etc., timely discover early lung cancer, and strive for the best time for treatment and intervention. 

药物成份或治疗方案详述:

无 

Description for medicine or protocol of treatment in detail:

None 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

明确诊断肺部结节的患者。 

Inclusion criteria

Patients with definite diagnosis of pulmonary nodules. 

排除标准:

①确诊为肺炎、肺结核的病人; ②研究信息缺失的病人。 

Exclusion criteria:

1. patients with pneumonia and tuberculosis; 2. patients lack of research information. 

研究实施时间:

Study execute time:

From2020-01-01To 2021-01-31 

干预措施:

Interventions:

组别:

肺结节

样本量:

1500

Group:

Pulmonary nodules

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):

四川省 

市(区县):

成都市 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川省肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Cancer Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

影像学表现

指标类型:

主要指标 

Outcome:

Imaging Manifestations Features

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:

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 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):

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 ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

电子病历

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

Hospital Information System

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:

电子病历

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

Hospital Information System

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-22
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