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China National Cancer Early Screening Trial: Lung and Colorectal Cancer
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注册号:

Registration number:

ChiCTR1900025257 

最近更新日期:

Date of Last Refreshed on:

2019-08-26 

注册时间:

Date of Registration:

2019-08-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国癌症早期筛查项目:肺癌和结直肠癌筛查多中心随机对照研究 

Public title:

China National Cancer Early Screening Trial: Lung and Colorectal Cancer 

注册题目简写:

CHANCES 

English Acronym:

CHANCES 

研究课题的正式科学名称:

中国癌症早期筛查项目:肺癌和结直肠癌筛查多中心随机对照研究 

Scientific title:

China National Cancer Early Screening Trial: Lung and Colorectal Cancer 

研究课题代号(代码):

Study subject ID:

2018YFC1312100,2017YFC1308700,2018YFC1315000 

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:

李霓 

研究负责人:

赫捷 

Applicant:

Ni Li 

Study leader:

Jie He 

申请注册联系人电话:

Applicant telephone:

+86 010-87788662 

研究负责人电话:

Study leader's telephone:

+86 010-87788662 

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:

weny515@126.com 

研究负责人电子邮件:

Study leader's E-mail:

nli@cicams.ac.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:

北京市朝阳区潘家园南里17号 

研究负责人通讯地址:

北京市朝阳区潘家园南里17号 

Applicant address:

17 Panjiayuan Street South, Chaoyang District, Beijing, China 

Study leader's address:

17 Panjiayuan Street South, Chaoyang District, Beijing, 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:

国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院 

Applicant's institution:

National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College 

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:

19/167-1951 

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:

国家癌症中心/中国医学科学院北京协和医学院肿瘤医院伦理委员会  

Name of the ethic committee:

Ethics Committee of National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-03 

伦理委员会联系人:

吴大维 

Contact Name of the ethic committee:

Dawei Wu 

伦理委员会联系地址:

北京市朝阳区潘家园南里17号 

Contact Address of the ethic committee:

17 Panjiayuan Street South, Chaoyang District, Beijing, 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:

国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院 

Primary sponsor:

National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College 

研究实施负责(组长)单位地址:

北京市朝阳区潘家园南里17号 

Primary sponsor's address:

17 Panjiayuan Street South, Chaoyang District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院

具体地址:

北京市朝阳区潘家园南里17号

Institution
hospital:

National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Address:

17 Panjiayuan Street South, Chaoyang District, Beijing, China

经费或物资来源:

国家重点研发计划 国家重大公共卫生服务项目-城市癌症早诊早治项目 

Source(s) of funding:

National Key R&D Program of China, Cancer Screening Program in Urban China (CanSPUC) 

研究疾病:

肺癌和结直肠癌 

Target disease:

lung and colorectal 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:

其它 

Study phase:

N/A 

研究目的:

(1)主要研究目的: 1、探讨LDCT筛查能否降低中国城市肺癌高危人群的肺癌死亡率; 2、若筛查组肺死亡率下降显著,则进行以下两两比较: ①连年LDCT和未筛查组; ②隔年LDCT和未筛查组; ③连年LDCT和隔年LDCT组 (2)次要研究目的 1、探究FIT或结肠镜筛查能否降低中国城市结直肠癌高危人群的结直肠癌死亡率,若筛查组结直肠癌死亡率下降显著,则进一步比较每年FIT筛查组和单次结肠镜筛查组之间结直肠癌死亡率的差异 2、测定肺癌和结直肠癌筛查技术的灵敏度、特异度、阳性预测值和阴性预测值 3、比较筛查组和未筛查组的肺癌和结直肠癌的分期、生存及其他临床、病理特征 4、追踪肺结节的进展和转化过程,以识别提示需要临床干预的预警事件 5、探究中国城市居民肺癌和结直肠癌发病和死亡的流行病学危险因素 6、开展用于收集、处理和解释LDCT扫描图像数据的医学影像技术研究 7、开展肺癌和结直肠癌的肿瘤发生和进展相关因素的分子生物、基因组研究,以及这些因素的早期检测和定量测定 8、评估在中国城市高危人群中本研究所采用的筛查技术的依从性(筛查意愿、脱落原因和居民满意度)、成本-效益和生活质量 9、探索提高FIT阳性者结肠镜检查参与率的方法  

Objectives of Study:

Primary objectives: 1.To determine whether screening with LDCT scan can reduce lung cancer-specific mortality in Chinese urban residents who are at high risk for developing lung cancer. 2.And if there is a significant lung cancer-specific mortality reduction in screening groups, to compare lung cancer-specific mortality between different screening groups: –Annual LDCT screening vs. no screening –Biennial LDCT screening vs. no screening –Annual LDCT screening vs. biennial LDCT screening Secondary objectives 1.To determine whether screening with FIT or colonoscopy can reduce colorectal cancer-specific mortality in Chinese urban residents. And if there is a significant colorectal cancer-specific mortality reduction in screening groups, to compare colorectal cancer-specific mortality between Chinese urban residents received annual FIT screening vs one-time colonoscopy screening. 2.??To assess screening variables,other than nortality,for each of the screening techniques for lung and colorectal cancer including sensitivity,specificity,positive and negative predictive value. 3.To compare the stage specific frequencies of diagnosis,survival and other clinicalpathological characteristics of cancer cases identified in screening and usual care. 4.To follow the development and transformation process of lung nodules to identify alerting event that inform surgical intervention. 5.To identify epidemiological risk factors for lung and colorectal cancer carcinogenesis and mortality in Chinese urban residents. 6.To conduct research on medical imaging techology for gathering,processing and interpreting the low dose CT scan image data. 7.To conduct biomolecular and genomic research into factors associated with tumorigenesis and progression of lung and colorectal cancer,as well and the early detection and quantification of these factors. 8.To assess the comliance (intention to participate,reasons for drop-off,satisfaction),cost-effectiveness,quality of life for each of the screening techniques in high risk populations in urban China. 9.To compare methods to enhance participants conpliance rate to colonoscopy after posotive findings in FIT test. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)50-74岁 (2)为本市常住户籍人口(居住时间≥5年以上) (3)具有完全的民事行为能力 (4)至少符合以下一项危险因素: ①吸烟≥30包年,其中也包括曾经吸烟≥30包年,但戒烟不足15 年者; ②既往诊断患有慢性阻塞性肺疾病(COPD),或者弥漫性肺间质纤维化 ③有职业暴露史(至少≥5年)(石棉、氡、铍、铀、铬、镉、镍、硅、矽、柴油废气、煤烟和煤烟灰) ④不吸烟女性:一起共同生活的家人或工作的同事吸烟≥30包年,也包括曾经吸烟≥30包年,但戒烟不足15 年者;需要跟吸烟者一起生活或工作≥20年。 (5)愿意遵从研究方案:①研究对象正式进入研究前同意签署知情同意书;②愿意填写研究对象《个人信息记录表》、《危险因素与联系信息调查表》;③愿意提供生物样本(血液、粪便等)。 (6)肺结核患者在治愈2年以后可以纳入研究。 (7)愿意完整接受社区人员后续的长期随访。 注:参加结直肠癌筛查5年以后或肺癌筛查3年以后的人优先纳入本研究。 

Inclusion criteria

1. Aged 50~74 years old; 2. Permanent residents of the city where the screening site located (length of residency≥5 years); 3. Citizen with full legal capacity for civil capacity; 4. Have any one of the following risk factors: (1) Smoking history>=30 pack-years with a subsequent smoking cessation <=15 years; (2) Patients with chronic obstructive pulmonary disorder (COPD), or a history of diffuse interstitial pulmonary fibrosis; (3) Occupational exposure history >=5 years (asbestos, radon, beryllium, uranium, chromium, cadmium, nickel, silicon, diesel exhaust, soot and soot ash); (4) Non-smoking women: second hand smoking from family members who live together or coworkers in the same room with a smoking history >=30 pack-years with a subsequent smoking cessation <=15 years and living or working with smokers >= 20 years; 5. Willing to comply with the research protocol: (1) Agree to sign informed consent before entering the research; (2) Willing to fill out Personal Information Record Form and Risk Factors and Contact Information Questionnaire; (3) Willing to provide biospecimens for detection and research, including (but not limited to) blood and feces; 6. The tuberculosis patients that have been cured for at least two years 7. Willing to finish long-term follow-up conducted by community health care personnel. Notes: Participants who participated in colorectal cancer screening after 5 years or lung cancer screening after 3 years were given priority in this study. 

排除标准:

所有研究对象若符合以下任一项条件即排除入组: (1)存在医学或精神方面的问题,无法完成知情同意。 (2)目前身体状况无法接受胸外科手术或放疗。 (3)胸部或背部有金属植入物或金属设备(心脏支架、心脏起搏器等),会影响肺部成像质量。 (4)不能完成标准的LDCT筛查:①需要吸氧才能保证呼吸功能,不能屏气;②仰卧时不能把胳膊举放在头上的人。 (5)本人有恶性肿瘤病史或者接受过癌症治疗(不包括皮肤基底细胞癌、子宫颈原位癌)。 (6)过去5年内做过结肠镜、纤维乙状结肠镜、气钡双对比造影、CT仿真结肠镜检查 (7)在过去36个月内做过胸部CT检查 (8)曾经手术切除过肺组织(包括全肺、肺叶、亚肺叶、肺段、楔形,不包括肺穿刺、肺活检) (9)有肺癌症状,包括不明原因的体重减少(过去12个月内体重减少5公斤以上),或不明原因的咳血。 (10)患有某些可引发生命危险的疾病,如严重的心脑血管疾病、严重肾病、肝硬化等。 (11)过去5年内参加过结直肠癌或过去3年内参加过肺癌筛查或防癌相关的研究。 

Exclusion criteria:

1. Unable to complete the informed consent procedure due to any physical or mental illness; 2. The current physical condition is not acceptable for thoracic surgery or radiotherapy; 3. Metal implants or metal facilities on chest or back (heart stents, cardiac pacemakers, etc); 4. Unable to finish standard LDCT screeninh: (1) Unable to ensure respiratory function without oxygen supply; (2) Unable to raise arms over head while lying on back; 5. History of malignancy or have received cancer treatment before (excluding skin basal cell carcinoma and cervical carcinoma in situ); 6. Have been included in colonoscopy, fiber sigmoidoscopy, double contrast angiography, CT simulation colonoscopy in the last 5 years; 7. Have been included in chest CT scan in last 36 months; 8. Received surgical resection of lung tissue (including whole lung, lung lobe, sublobular lobe, lung segment and wedge shape, excluding lung puncture and lung biopsy); 9. Unexplained weight loss of 5 kilograms or more within the past 12 months or unexplained hemoptysis; 10. Suffering from certain life-threatening diseases, including severe cardiac-cerebral vascular diseases, heart failure, kidney failure, severe liver cirrhosis, etc; 11. Have been included in any other lung screening programs in the last 5 years and/or colorectal cancer screening programs in the last 3 years. 

研究实施时间:

Study execute time:

From2019-05-01To 2028-12-31 

征募观察对象时间:

Recruiting time:

From2019-08-15To 2020-08-15 

干预措施:

Interventions:

组别:

A组

样本量:

28800

Group:

Group A

Sample size:

干预措施:

每年LDCT (共5次)+任意一年结肠镜(1次,推荐第一年)

干预措施代码:

Intervention:

Annual LDCT (5 rounds) and colonoscopy for any year (first year is recommended)

Intervention code:

组别:

B组

样本量:

43200

Group:

Group B

Sample size:

干预措施:

隔年LDCT(共3次)+每年FIT(共5次),FIT阳性者行结肠镜检查

干预措施代码:

Intervention:

Biennial LDCT (3 rounds) and annual FIT (5 rounds), those who have FIT positive results will undertake colonoscopy

Intervention code:

组别:

C组

样本量:

43200

Group:

Group C

Sample size:

干预措施:

告知肺癌高危,推荐去正规医疗机构做肺癌筛查;推荐进行结肠镜检查(5年,共1次),不愿意接受结肠镜检查者进行FIT检查(5年,共5次),FIT阳性者行结肠镜检查

干预措施代码:

Intervention:

To inform the participants of high risk of lung cancer and recommend them to undertake lung cancer screening in other regular medical institutions; To recommend colonoscopy for any year (first year is recommended), and those who are unwilling to undertake colonoscopy will receive FIT screening (5 rounds), those

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

湖南省肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Hunan Cancer Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Zehjiang Cancer Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

云南省肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Yunnan Cancer Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

甘肃 

市(区县):

 

Country:

China 

Province:

Gansu 

City:

 

单位(医院):

甘肃省医学科学研究院 

单位级别:

三甲医院 

Institution
hospital:

Gansu Provincial Academic Institute for Medical Research  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

中国医学科学院肿瘤医院深圳分院 

单位级别:

三甲医院 

Institution
hospital:

Cancer Hopital Chinese Academy of Medical Sciences Shenzhen Center  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

河南省肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Henan Cancer Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Chongqing Cancer Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

徐州市肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Xuzhou Cancer Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽省肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Anhui Cancer Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

肺癌死亡率

指标类型:

主要指标 

Outcome:

lung cancer mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

结直肠癌死亡率

指标类型:

主要指标 

Outcome:

colorectal cancer mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

分期前移

指标类型:

次要指标 

Outcome:

stage shift

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺结节检出率

指标类型:

次要指标 

Outcome:

detection rate of lung nodules

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

结直肠癌前病变检出率

指标类型:

次要指标 

Outcome:

detection rate of colorectal precancerous lesions

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺癌检出率

指标类型:

次要指标 

Outcome:

detection rate of lung cancer

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

结直肠癌检出率

指标类型:

次要指标 

Outcome:

detection rate of colorectal cancer

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

I期肺癌/结直肠癌占比

指标类型:

次要指标 

Outcome:

proportion of stage I cases

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全死因死亡率

指标类型:

次要指标 

Outcome:

all-cause mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性(筛查相关的并发症或死亡)

指标类型:

副作用指标 

Outcome:

screening related complications & death

Type:

Adverse events 

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:

blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

feces

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

肺组织

组织:

Sample Name:

lung tissue

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

结直肠组织

组织:

Sample Name:

colorectal tissue

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 50 years
最大 Max age 74 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):

中国医学科学院肿瘤医院总项目组数据中心通过计算机软件实施随机化,以中心控制的方式进行。

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

Randomization will be conducted in computer software by the data center of the general project team in Cancer Hospital Chinese Academy of Medical Sciences, and it will be relised in a centrally controled manner.

盲法:

Open label

Blinding:

Open label

是否共享原始数据:

IPD sharing

Yes

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):

科研论文

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

research paper

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:

数据采集通过网络版录入,数据包括基本的人口学信息、诊断、治疗、随访以及其他信息

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

Data will be collected through network version. The database contain basic demographic information, diagnosis, treatment, follow-up and other information.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-18
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