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A cohort study on colorectal cancer screening among urban residents in Shenzhen
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注册号:

Registration number:

ChiCTR2100052706 

最近更新日期:

Date of Last Refreshed on:

2022-04-27 

注册时间:

Date of Registration:

2021-11-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请与我们联系上传伦理审批文件。 深圳市城市居民结直肠癌筛查队列研究 

Public title:

A cohort study on colorectal cancer screening among urban residents in Shenzhen 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

结直肠癌筛查全周期的队列研究 

Scientific title:

A cohort study on the whole cycle of colorectal 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:

刘芳江 

研究负责人:

彭绩 

Applicant:

Liu Fangjiang 

Study leader:

Peng Ji 

申请注册联系人电话:

Applicant telephone:

+86 18820475481 

研究负责人电话:

Study leader's telephone:

+86 13602658282 

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:

lufangjiang1994@163.com 

研究负责人电子邮件:

Study leader's E-mail:

pengji126@126.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:

广东省深圳市罗湖区布心路2021号 

研究负责人通讯地址:

广东省深圳市罗湖区布心路2021号 

Applicant address:

2021 Buxin Road, Luohu District, Shenzhen, Guangdong 

Study leader's address:

2021 Buxin Road, Luohu District, Shenzhen, Guangdong 

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:

深圳市慢性病防治中心 

Applicant's institution:

Shenzhen Chronic Disease Control Center 

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:

深圳市慢性病防治中心 

Primary sponsor:

Shenzhen Chronic Disease Control Center 

研究实施负责(组长)单位地址:

广东省深圳市罗湖区布心路2021号 

Primary sponsor's address:

2021 Buxin Road, Luohu District, Shenzhen, Guangdong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市慢性病防治中心

具体地址:

罗湖区布心路2021号

Institution
hospital:

Shenzhen Chronic Disease Control Center

Address:

2021 Buxin Road, Luohu District

经费或物资来源:

政府资助、单位自筹 

Source(s) of funding:

Government funding, workplace self-financed 

研究疾病:

结直肠癌 

Target disease:

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. 建立和完善覆盖结直肠癌筛查全周期的筛查研究队列; 2. 构建和优化多维度动态随访数据库及与之匹配的生物样本库; 3. 探索结直肠癌的主要危险因素及其流行现状,明确不同暴露因素和人群差异对结直肠恶化潜能的影响; 4. 明确筛查人群中结直肠癌的进展过程以及不良结局(癌症、死亡等)的发生率,分析影响其发展和预后的危险因素,进行重点防治; 5. 筛选出具有针对性的肿瘤标志物,进一步提升筛查效率; 6. 将研究结果应用于判断临床治疗效果并筛选潜在的肿瘤预后标志物,为结直肠癌临床指南提供修订的依据。 

Objectives of Study:

1. Establish and improve screening research cohorts covering the full cycle of colorectal cancer screening; 2. Construct and optimize a multi-dimensional dynamic follow-up database and its matching biological sample library; 3. Explore the main risk factors of colorectal cancer and its prevalence, and to clarify the impact of different exposure factors and population differences on the potential for colorectal deterioration; 4. Identify the progression of colorectal cancer and the incidence of adverse outcomes (cancer, death, etc.) in the screening population, analyze the risk factors affecting its development and prognosis, and carry out key prevention and treatment; 5. Screen out targeted tumor markers to further improve the screening efficiency; 6. Apply the research results to judging clinical treatment effects and screening potential tumor prognostic markers to provide a basis for revision of clinical guidelines for colorectal cancer. 

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:

深圳市10个区(含功能区)年龄45-74周岁(以身份证上出生日期为准)常住居民(在本地居住三年以上),自愿参加并愿意长期随访者。 

Inclusion criteria

Residents of 10 districts (including functional areas) in Shenzhen, aged 45-74 years (based on the date of birth on the ID card), are permanent residents (who have lived in the area for more than three years), who voluntarily participate and are willing to follow up for a long time. 

排除标准:

1.有结直肠癌病史;目前正在接受癌症的相关治疗; 2.近两年有胸部影像学(CT、X线、MRI等)检查;近两年参加过结肠镜、免疫法粪便隐血试验或其他类型的结直肠癌筛查; 3.有精神性疾病; 4.无民事行为能力,不能签署知情同意书的居民。 

Exclusion criteria:

1. Have a history of colorectal cancer; are currently receiving cancer-related treatment; 2. Have chest imaging (CT, X-ray, MRI, etc.) examinations in the past two years; have participated in colonoscopy, immune fecal occult blood test or other types of colorectal cancer screening in the past two years; 3. Mental illness; 4. Residents who have no capacity for civil conduct and cannot sign informed consent. 

研究实施时间:

Study execute time:

From2022-01-01To 2027-01-01 

征募观察对象时间:

Recruiting time:

From2021-11-15To 2021-12-31 

干预措施:

Interventions:

组别:

连续入组

样本量:

50000

Group:

case series

Sample size:

干预措施:

结直肠镜

干预措施代码:

Intervention:

Colonoscopy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市慢性病防治中心 

单位级别:

 

Institution
hospital:

Shenzhen Centre for Chronic Disease Control  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

结直肠癌

指标类型:

主要指标 

Outcome:

colorectal cancer

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

癌前病变

指标类型:

主要指标 

Outcome:

precancerous lesions

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 45 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):

按照上述纳入标准,采取整群抽样的方法选定目标人群。卫生行政部门和协调相关部门利用各种媒体、宣传材料和科普讲座等形式进行宣传,动员群众参加项目,说明项目的背景和意义;根据方案的要求,以社区为单位摸清符合纳入标准的目标人群,在符合条件的人群中确定参加对象,并填报姓名和基本信息,最终确定人群参与名单。

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

According to the above inclusion criteria, the target population was selected by cluster sampling. The administrative department of health and the relevant coordination departments shall use various media, publicity materials and popular science lectures to publicize, mobilize the masses to participate in the project and&#

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):

所有调查及生物样本检测结果将存储于“深圳市慢性病防治管理系统”,数据以分析报告或学术论文形式对外分享。原则上原始数据不对外共享,对原始数据有需求的工作人员,可与项目负责人取得联系,征得同意后方可使用。

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

All survey and biological sample test results will be stored in the

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:问卷调查有被培训的调查员收集,在调查前由项目组同意组织进行培训。数据管理:所有调查以及生物样本所有调查及生物样本检测结果将存储于“深圳市慢性病防治管理系统”,项目成立数据管理小组,由专人负责数据的存储及运输。

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

Data collection: the questionnaire survey is collected by trained investigators, and the project team agrees to organize training before the survey. Data management: all surveys and biological samples, all survey and biological sample test results will be stored in "Shenzhen chronic disease prevention and control management system". A data management team will be established for the project, and a special person will be responsible for data storage and transportation.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2021-11-03
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