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生理通气辅助超高分辨率CT扫描技术对肺部恶性纯磨玻璃结节的侵袭性预测和精确诊断价值
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注册号:

Registration number:

ChiCTR1900024608 

最近更新日期:

Date of Last Refreshed on:

2019-07-18 

注册时间:

Date of Registration:

2019-07-18 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

生理通气辅助超高分辨率CT扫描技术对肺部恶性纯磨玻璃结节的侵袭性预测和精确诊断价值 

Public title:

Values of Ventilation-assisted Ultra-high Resolution CT Imaging in Invasiveness Prediction and Accurate Diagnosis of Pulmonary Malignant Pure Ground-glass Nodules 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

生理通气辅助超高分辨率CT扫描技术对肺部恶性纯磨玻璃结节的侵袭性预测和精确诊断价值 

Scientific title:

Values of Ventilation-assisted Ultra-high Resolution CT Imaging in Invasiveness Prediction and Accurate Diagnosis of Pulmonary Malignant Pure Ground-glass 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:

李惠民 

研究负责人:

李惠民 

Applicant:

Huimin Li 

Study leader:

Huimin Li 

申请注册联系人电话:

Applicant telephone:

+86 13916626047 

研究负责人电话:

Study leader's telephone:

+86 13916626047 

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:

lihuimin@xinhuamed.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

lihuimin@xinhuamed.com.cn 

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:

上海市杨浦区控江路1665号 

研究负责人通讯地址:

上海市杨浦区控江路1665号 

Applicant address:

1665 Kongjiang Road, Yangpu District, Shanghai, China 

Study leader's address:

1665 Kongjiang Road, Yangpu District, 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:

上海交通大学医学院附属新华医院 

Applicant's institution:

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine 

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:

XHEC-C-2018-057-2 

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:

上海交通大学医学院附属新华医院伦理委员会 

Name of the ethic committee:

Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiaotong University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-30 

伦理委员会联系人:

施敏 

Contact Name of the ethic committee:

Min Shi 

伦理委员会联系地址:

上海市杨浦区控江路1665号 

Contact Address of the ethic committee:

1665 Kongjiang Road, Yangpu District, 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:

上海交通大学医学院附属新华医院 

Primary sponsor:

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine 

研究实施负责(组长)单位地址:

上海市杨浦区控江路1665号 

Primary sponsor's address:

1665 Kongjiang Road, Yangpu District, 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):

上海交通大学医学院附属新华医院

具体地址:

上海市杨浦区控江路1665号

Institution
hospital:

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Address:

1665 Kongjiang Road, Yangpu District, Shanghai, China

经费或物资来源:

申请基金 

Source(s) of funding:

To apply for founds 

研究疾病:

肺腺癌 

Target disease:

lung adenocarcinoma 

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:

探索性研究/预试验 

Study phase:

研究目的:

评估生理通气辅助超高分辨率CT扫描技术对肺纯磨玻璃结节侵袭性的预测价值,同时探索恶性纯磨玻璃结节的侵袭程度CT判断要点、具有鉴别诊断价值的特殊CT征象。 

Objectives of Study:

We aimed to investigate the values of G-protocol in the prediction of invasiveness of pure ground-glass nodules. In the meantime, we sought to explore the diagnostic points of G-protocol CT images in the degree of invasiveness of pure ground-glass nodule and the special CT signs with diagnostic values. 

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:

临床发现GGN并建议行G-protocol扫描的患者;年龄18-80岁;第一部分患者需签署知情同意书,肺纯磨玻璃结节,直径>0.5cm,≤3cm;第二、三部分患者具有明确病理结果。 

Inclusion criteria

Patients with clinically found GGN and G-protocol scanning was recommended; Aged 18 to 80 years old; Patients of the first part need to sign the informed consent; Pulmonary pure groud-glass nodules, the diameter of the Nodules: >0.5cm,<=3cm; GGNs were pathologically confirmed in the second and third part. 

排除标准:

GGN直径≤0.5cm或>3cm;实性或部分实性结节;CT禁忌症;由于任何原因不适合参加. 

Exclusion criteria:

The diameter of the Nodules: <=0.5cm or >3cm; Pulmonary nodules are solid or sub-solid; Patients with CT contraindications; Patients are not eligible to participate for any reason. 

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 2020-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

430

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

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):

上海交通大学医学院附属新华医院 

单位级别:

三甲医院 

Institution
hospital:

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

结节大小

指标类型:

主要指标 

Outcome:

nodule size

Type:

Primary indicator 

测量时间点:

术前CT检查完成后

测量方法:

在后处理工作站上手工测量

Measure time point of outcome:

Last CT scan before operation

Measure method:

Measure manually in the post-processing workstation

指标中文名:

结节密度

指标类型:

主要指标 

Outcome:

nodule density

Type:

Primary indicator 

测量时间点:

术前CT检查完成后

测量方法:

在后处理工作站上手工测量

Measure time point of outcome:

Last CT scan before operation

Measure method:

Measure manually in the post-processing workstation

采集人体标本:

Collecting sample(s)
from participants:

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 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:

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):

联系实验者公开; ResMan

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

contact with the applicant; ResMan

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:

CRF,eCRF

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

CRF,eCRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-07-18
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