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A prospective, multicenter cohort study of pan-cancer screening in Chinese population
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注册号:

Registration number:

ChiCTR2100053705 

最近更新日期:

Date of Last Refreshed on:

2022-05-18 

注册时间:

Date of Registration:

2021-11-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国人群前瞻性、多中心泛癌早筛队列研究 

Public title:

A prospective, multicenter cohort study of pan-cancer screening in Chinese population 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

前瞻性、多中心、非干预、泛癌多组学早筛模型队列研究 

Scientific title:

A prospective, multicenter, noninterventional cohort study of muti-omics models for pan-cancer screening 

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:

邹文 

研究负责人:

陈兴栋 

Applicant:

Zou Wen 

Study leader:

Chen Xingdong 

申请注册联系人电话:

Applicant telephone:

+86 15152621812 

研究负责人电话:

Study leader's telephone:

+86 13564793419 

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:

zouwen@fdtzihs.org.cn 

研究负责人电子邮件:

Study leader's E-mail:

xingdongchen@fudan.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

复旦大学泰州健康科学研究院 

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:

泰州医药高新区药城大道799号 

研究负责人通讯地址:

泰州医药高新区药城大道799号 

Applicant address:

799 Yaocheng Avenue, Taizhou Pharmaceutical High-Tech Zone, Taizhou, Jiangsu, China 

Study leader's address:

799 Yaocheng Avenue, Taizhou Pharmaceutical High-Tech Zone, Taizhou, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

225300 

研究负责人邮政编码:

Study leader's postcode:

225300 

申请人所在单位:

复旦大学泰州健康科学研究院 

Applicant's institution:

Fudan University Taizhou Institute of Health Sciences 

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:

B016 

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:

复旦大学泰州健康科学研究院伦理委员会 

Name of the ethic committee:

Ethics Committee of Fudan University Taizhou Institute of Health Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-07-06 

伦理委员会联系人:

邹文 

Contact Name of the ethic committee:

Zou Wen 

伦理委员会联系地址:

泰州医药高新区药城大道799号 

Contact Address of the ethic committee:

799 Yaocheng Avenue, Taizhou Pharmaceutical High-Tech Zone, Taizhou, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 15152621812 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

zouwen@fdtzihs.org.cn 

研究实施负责(组长)单位:

复旦大学泰州健康科学研究院 

Primary sponsor:

Fudan University Taizhou Institute of Health Sciences 

研究实施负责(组长)单位地址:

泰州医药高新区药城大道799号 

Primary sponsor's address:

799 Yaocheng Avenue, Taizhou Pharmaceutical High-Tech Zone, Taizhou, Jiangsu, 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):

江苏

市(区县):

泰州

Country:

China

Province:

Jiangsu

City:

Taizhou

单位(医院):

复旦大学泰州健康科学研究院

具体地址:

医药高新区药城大道799号

Institution
hospital:

Fudan University Taizhou Institute of Health Sciences

Address:

799 Yaocheng Avenue, Taizhou Pharmaceutical High-Tech Zone, Taizhou

经费或物资来源:

上海鹍远生物技术有限公司 

Source(s) of funding:

Singlera Genomics Inc. 

研究疾病:

癌症 

Target disease:

Cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

筛查 

Study type:

Screening 

研究所处阶段:

诊断试验新技术临床试验 

Study phase:

Diagnostic New Technique Clincal Study 

研究目的:

主要目的: 1. 建立50000例自然人群3年随访队列,并基于该队列开发泛癌多组学早筛模型; 2. 建立10000例常规体检人群2年随访队列,并对早筛模型进行多中心验证,以评估该模型的敏感性、特异性、阳性预测值和阴性预测值; 3. 在泰州队列中对该模型进行测试,以评价该模型的预测效能。 

Objectives of Study:

Main purpose: 1. Establish a 3-year follow-up cohort of 50,000 natural populations, and develop a pan-cancer multi-omics early screening model based on the cohort; 2. Establish a 2-year follow-up cohort of 10,000 patients with routine physical examination, and conduct multi-center validation of the early screening model to evaluate the sensitivity, specificity, positive predictive value and negative predictive value of the model; 3. Test the model in the Taizhou cohort to evaluate the predictive performance of the model. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

1.年龄40-75周岁(含临界值),性别不限; 2.在研究中心体检且既往无肿瘤病史者; 3.入组后能够自愿按照本研究方案设计完成《人群健康跟踪调查——简化版调查问卷》并接受年度体检随访的受试者; 4.同意在研究过程及时的将外院就诊过程中与肿瘤诊断相关的信息反馈给研究者; 5.近3年没有生育计划者; 6.对本研究充分了解,且自愿签署知情同意书者。 

Inclusion criteria

1. Aged 40 to 75 years (including critical value), gender is not limited; 2. Physical examination in the research center and no history of tumor; 3. Subjects who can voluntarily complete the "Population Health Tracking Survey - Simplified Questionnaire" according to the design of this research program and receive annual follow-up physical examination; 4. Agree to timely feed back the information related to tumor diagnosis in the process of visiting a doctor in a foreign hospital to the researcher during the research process; 5. Those who have no family planning in the past 3 years; 6. Those who have a full understanding of this research and voluntarily sign the informed consent form. 

排除标准:

1.已确诊食管癌、胃癌、结直肠癌、肝癌、肺癌、胰腺癌、乳腺癌(包括非原发性,如复发、转移或其他并发症)及其他恶性肿瘤者; 2.3个月内接受过输血、移植手术等大型手术治疗者; 3.3个月内参加其他干预性临床研究者; 4.妊娠或哺乳期妇女; 5.患有自身免疫性疾病、遗传性疾病、精神疾病/残疾等研究者认为不适合参加本研究的疾病者; 6.依从性差,经研究者判断无法完成本研究者。 

Exclusion criteria:

1. Those who have been diagnosed with esophageal cancer, gastric cancer, colorectal cancer, liver cancer, lung cancer, pancreatic cancer, breast cancer (including non-primary, such as recurrence, metastasis or other complications) and other malignant tumors; 2. Those who have received major surgery such as blood transfusion and transplantation within 3 months; 3. Participate in other interventional clinical investigators within 3 months; 4. Pregnant or lactating women; 5. Those who suffer from autoimmune diseases, genetic diseases, mental diseases/disability and other diseases that the researchers consider unsuitable to participate in this study; 6. The compliance is poor, and it is judged by the researcher that the researcher cannot be completed. 

研究实施时间:

Study execute time:

From2021-07-06To 2024-01-07 

征募观察对象时间:

Recruiting time:

From2021-12-01To 2022-08-31 

干预措施:

Interventions:

组别:

Case series

样本量:

60000

Group:

Case series

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 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Provincial People's Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

中南大学湘雅医院 

单位级别:

三级甲等 

Institution
hospital:

Xiangya Hospital of Central South University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

中南大学湘雅三医院 

单位级别:

三级甲等 

Institution
hospital:

Third Xiangya Hospital of Central South University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医院附属协和医院 

单位级别:

三级甲等 

Institution
hospital:

Union Hospital affiliated to Tongji Hospital, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

中国科学技术大学附属第一医院(安徽省立医院) 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)  

Level of the institution:

Tertiary A 

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瑞金医院 

单位级别:

三级甲等 

Institution
hospital:

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

江苏省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Jiangsu Provincial People's Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Provincial People's Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

循环肿瘤DNA甲基化

指标类型:

主要指标 

Outcome:

ctDNA methylation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

循环肿瘤DNA突变

指标类型:

主要指标 

Outcome:

ctDNA mutation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

游离DNA片段特征

指标类型:

主要指标 

Outcome:

cfDNA fragmentation

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 40 years
最大 Max age 75 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):

NA

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

NA

盲法:

Blinding:

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):

NA

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

NA

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:

NA

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

NA

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2021-11-27
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