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Application of Circulating genetically abnormal Cells (CACs) in the diagnosis of sub-centimeter pulmonary nodules
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注册号:

Registration number:

ChiCTR2100054267 

最近更新日期:

Date of Last Refreshed on:

2021-12-12 

注册时间:

Date of Registration:

2021-12-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件。 循环染色体异常细胞(CAC)在亚厘米结节诊断中的应用探索 

Public title:

Application of Circulating genetically abnormal Cells (CACs) in the diagnosis of sub-centimeter pulmonary nodules  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

循环染色体异常细胞(CAC)在亚厘米结节诊断中的应用探索 

Scientific title:

Application of Circulating genetically abnormal Cells (CACs) in the diagnosis of sub-centimeter 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:

杨中烨 

研究负责人:

张毅 

Applicant:

Zhongye Yang 

Study leader:

Yi Zhang 

申请注册联系人电话:

Applicant telephone:

18911034771 

研究负责人电话:

Study leader's telephone:

13141370703 

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:

yangzhongye1107@126.com 

研究负责人电子邮件:

Study leader's E-mail:

steven9130@sina.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:

北京市西城区长椿街45号 

研究负责人通讯地址:

北京市西城区长椿街45号 

Applicant address:

No.45 Changchun Street, Xicheng District, Beijing 

Study leader's address:

No.45 Changchun Street, Xicheng District, Beijing 

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:

首都医科大学宣武医院 

Applicant's institution:

Xuanwu Hospital, Capital Medical University 

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:

首都医科大学宣武医院 

Primary sponsor:

Xuanwu Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市西城区长椿街45号 

Primary sponsor's address:

No.45 Changchun Street, Xicheng District, Beijing 

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):

首都医科大学宣武医院

具体地址:

北京市西城区长椿街45号

Institution
hospital:

Xuanwu Hospital, Capital Medical University

Address:

No.45 Changchun Street, Xicheng District, Beijing

经费或物资来源:

珠海圣美生物诊断技术有限公司 

Source(s) of funding:

SANMED BIOTECH 

研究疾病:

肺结节 

Target disease:

pulmonary nodule 

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:

本研究通过检测外周血循环染色体异常细胞,探究其在亚厘米结节患者中的外周血的含量,与术后病理之间的关系,同时结合患者临床病例资料构建早期肺癌(T1期肺癌)预测模型。对减少良性结节接受手术治疗提供可能性 

Objectives of Study:

This study explored the relationship between the blood in patients with sub-centimeter nodules and postoperative pathology by detecting abnormal circulating genetically cells. At the same time, combining the clinical\ data of the patients to construct an early lung cancer (T1 lung cancer) prediction model . Provides the possibility to reduce benign nodules undergoing surgical 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:

队列研究 

Study design:

Cohort study 

纳入标准:

(1)临床诊断为肺结节,最大结节直径≤1cm (2)年龄≥18周岁且≤80周岁 (3)患者可耐受手术治疗 (4)能够理解研究方案并自愿参与本研究,签署知情同意书 (5)能够配合采集样本,有完整的临床信息 

Inclusion criteria

(1)The clinically diagnose is pulmonary nodule, while the largest nodule diameter is no longer than 1cm (2) Age ≥18 years old , ≤80 years old (3) The patient can tolerate surgical treatment (4) Able to understand the research plan and voluntarily participate in this research, and sign the informed consent form (5) Able to collect samples and have complete clinical information 

排除标准:

(1)患者在手术前已接受化疗、放疗等抗肿瘤治疗 (2)患者因各种原因未接受手术治疗 (3)未于规定时间内采集外周血的患者 (4)确诊肺结节前5年内患有各种恶性肿瘤 (5)具有研究者认为不适合入选的任何其他情况 

Exclusion criteria:

(1) The patient has received chemotherapy, radiotherapy and other anti-tumor treatments before surgery (2) The patient did not receive surgery for various reasons (3) Patients who did not collect peripheral blood within the specified time (4) Suffered from various malignant tumors within 5 years before the diagnosis of lung nodule (5) Any other circumstances deemed unsuitable by the researcher 

研究实施时间:

Study execute time:

From2021-11-29To 2022-11-29 

征募观察对象时间:

Recruiting time:

From2022-11-29To 2027-11-29 

干预措施:

Interventions:

组别:

None

样本量:

30

Group:

None

Sample size:

干预措施:

None

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):

首都医科大学宣武医院 

单位级别:

三级甲等医院 

Institution
hospital:

Xuanwu Hospital, Capital Medical University  

Level of the institution:

Grade III, class A 

测量指标:

Outcomes:

指标中文名:

循环染色体异常细胞

指标类型:

主要指标 

Outcome:

Circulating genetically Abnormal Cell

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:

Sample Name:

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 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):

无随机

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

None

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

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

None

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:

采用病例报告表CRF记录每一例病例的数据,使用Excel表格进行数据统计

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

Use the case report form (CRF) to record the data of each case, and use the Excel table for data statistics

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-12
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