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whole-body early cancer detection using 18F-FDG PET/MR combined with chest CT in asymptomatic subjects
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注册号:

Registration number:

ChiCTR2200060041 

最近更新日期:

Date of Last Refreshed on:

2022-05-16 

注册时间:

Date of Registration:

2022-05-16 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

基于PET/MR联合胸部CT在健康人群中的全身肿瘤早期检测 

Public title:

whole-body early cancer detection using 18F-FDG PET/MR combined with chest CT in asymptomatic subjects 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

18F-FDG PET/MR联合胸部CT在无症状人群肿瘤早期检测中的应用 

Scientific title:

The performance of 18F-FDG PET/MR combined with chest CT for whole-body early cancer detection in asymptomatic subjects 

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:

高欣 

研究负责人:

高欣 

Applicant:

Xin Gao 

Study leader:

Xin Gao 

申请注册联系人电话:

Applicant telephone:

15901613704 

研究负责人电话:

Study leader's telephone:

15901613704 

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:

gaoxin@uvclinic.cn 

研究负责人电子邮件:

Study leader's E-mail:

gaoxin@uvclinic.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:

上海市徐汇区桂林路406号华鑫中心8号楼 

研究负责人通讯地址:

上海市徐汇区桂林路406号华鑫中心8号楼 

Applicant address:

No.8 Building, Huaxin Business Center, 406 Guilin Road, Xuhui District, Shanghai, P.R.China 

Study leader's address:

No.8 Building, Huaxin Business Center, 406 Guilin Road, Xuhui District, Shanghai, P.R.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:

上海全景医学影像诊断中心 

Applicant's institution:

Shanghai Universal Medical Imaging Diagnostic Center 

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:

SECCR/2021-125-01 

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:

上海市临床研究伦理委员会 

Name of the ethic committee:

SHANGHAI ETHICS COMMITTEE FOR CLINICAL RESEARCH 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-09-27 

伦理委员会联系人:

张红霞 

Contact Name of the ethic committee:

Hongxia Zhang 

伦理委员会联系地址:

上海市徐汇区枫林路 380 号 A 座 18 层 

Contact Address of the ethic committee:

18th Floor, Block A, No.380, Fenglin Road, Xuhui District, Shanghai 

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:

上海全景医学影像诊断中心 

Primary sponsor:

Shanghai Universal Medical Imaging Diagnostic Center 

研究实施负责(组长)单位地址:

上海市徐汇区桂林路406号华鑫中心8号楼 

Primary sponsor's address:

Shanghai Universal Medical Imaging Diagnostic Center 

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):

上海全景医学影像诊断中心

具体地址:

徐汇区桂林路406号华鑫中心8号楼

Institution
hospital:

Shanghai Universal Medical Imaging Diagnostic Center

Address:

Building 8,Huaxin Center, No.406 Guilin Road, Xuhui District, Shanghai

经费或物资来源:

全景自主研发课题 

Source(s) of funding:

Independent research and development project of Shanghai Universal Medical Imaging Diagnostic Center Co., LTD. 

研究疾病:

无症状人群 

Target disease:

asymptomatic subjects 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

评估全身18F-FDG PET/MR联合胸部CT在无症状人群中进行癌症早期检测的诊断性能。 

Objectives of Study:

To evaluate the diagnostic performance of whole-body 18F-fluorodeoxyglucose positron emission tomography/magnetic resonance (18F-FDG PET/MR) combined with chest computerized tomography (CT) in whole-body early cancer detection on a large cohort of asymptomatic subjects. 

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:

进行过PET/MR全身检查和胸部CT检查的无症状健康人群,部分研究对象(1210/3020)进行过血液肿瘤检测。 

Inclusion criteria

A total of 3243 consecutive asymptomatic subjects comprised the study population. All subjects underwent 18F FDG PET/MR and chest CT imaging, and a portion of them (1210/3020) also underwent common serum tumor marker examination (including carcinoembryonic antigen (CEA), carbohydrate antigen (CA), alpha-fetoprotein (AFP), cytokeratin 19 fragments (CYFRA21-1), Prostate-specific antigen (PSA), squamous cell carcinoma antigen (SCC-Ag), neuron-specific enolase (NSE) and ferritin). 

排除标准:

1.有癌症病史或者典型癌症临床表现; 2.有明确的癌前病变,比如黏膜白斑病,家族性腺瘤性息肉病,肝硬化; 3.随访时间不足或随访期间未进行进一步检测确定是否有肿瘤。 

Exclusion criteria:

1.had history or typical symptoms of cancers 2.had precancerous lesions, such as leukoplakia, Familial adenomatous polyposis, cirrhosis. 3.were lost to follow-up or performed no further examinations during the follow-up. 

研究实施时间:

Study execute time:

From2016-04-30To 2022-03-23 

征募观察对象时间:

Recruiting time:

From2016-04-30To 2022-03-23 

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):

病理诊断

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):

Pathological diagnosis

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):

全身18F-FDG PET/MR联合胸部CT

Index test:

whole-body 18F-fluorodeoxyglucose positron emission tomography/magnetic resonance (18F-FDG PET/MR) combined with chest computerized tomography (CT)

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)

无症状健康人群

例数:

Sample size:

3243

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):

Healthy asymptomatic subjects

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):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海全景医学影像诊断中心 

单位级别:

民营医院 

Institution
hospital:

Shanghai Universal Medical Imaging Diagnostic Center  

Level of the institution:

Private hospital 

测量指标:

Outcomes:

指标中文名:

癌症检出率

指标类型:

主要指标 

Outcome:

detection rate of caners

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

特异性

指标类型:

主要指标 

Outcome:

specificity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阳性预测值和阴性预测值

指标类型:

次要指标 

Outcome:

PPV and NPV

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

敏感性

指标类型:

主要指标 

Outcome:

sensitivity

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

其它 

说明

Fate of sample:

Others 

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 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):

不适用

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):

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):

ResMan 临床试验公共管理平台, http://www.medresman.org.cn

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

ResMan, http://www.medresman.org.cn.

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:

病例记录表以编码代替患者身份信息,源数据保存于研究机构专用电脑中,并对保存电脑进行加密,由专人负责保管。

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

The case record form replaces the patient's identity information with code. The source data is saved in a special computer of the research institution, and the saved computer is encrypted and kept by a specially assigned person.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-05-16
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