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Work Plan of the Gastric Cancer Screening Project for Rural Residents in Weihai City
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注册号:

Registration number:

ChiCTR2100054553 

最近更新日期:

Date of Last Refreshed on:

2021-12-19 

注册时间:

Date of Registration:

2021-12-19 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

此为补注册,需在www.medresman.org上建立项目、审核原始数据并公示后才能补注册 威海市农村居民筛查项目 

Public title:

Work Plan of the Gastric Cancer Screening Project for Rural Residents in Weihai City 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

威海市农村居民筛查项目 

Scientific title:

Work Plan of the Gastric Cancer Screening Project for Rural Residents in Weihai City 

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:

赵钦府 

研究负责人:

褚衍六 

Applicant:

Qinfu Zhao 

Study leader:

Yanliu Chu 

申请注册联系人电话:

Applicant telephone:

18660378823 

研究负责人电话:

Study leader's telephone:

18615161167 

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:

QinfuZhao@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

QinfuZhao@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

威海市立医院 

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:

山东省威海市环翠区和平路70号 

研究负责人通讯地址:

山东省威海市环翠区和平路70号 

Applicant address:

70 Heping Road, Huancui District, Weihai City, Shandong Province, China 

Study leader's address:

70 Heping Road, Huancui District, Weihai City, Shandong Province, 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:

威海市立医院 

Applicant's institution:

威海市立医院 

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:

2020050 

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:

威海市立医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Weihai Municipal Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-12-03 

伦理委员会联系人:

邢宗杰 

Contact Name of the ethic committee:

Zongjie Xing 

伦理委员会联系地址:

山东省威海市环翠区和平路70号 

Contact Address of the ethic committee:

70 Heping Road, Huancui District, Weihai City, Shandong Province, 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:

威海市立医院 

Primary sponsor:

Weihai Municipal Hospital 

研究实施负责(组长)单位地址:

山东省威海市环翠区和平路70号 

Primary sponsor's address:

70 Heping Road, Huancui District, Weihai City, Shandong Province, 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):

山东

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

威海市立医院

具体地址:

山东省威海市环翠区和平路70号

Institution
hospital:

Weihai Municipal Hospital

Address:

70 Heping Road, Huancui District, Weihai City, Shandong Province, China

经费或物资来源:

威海市财政局 

Source(s) of funding:

Weihai Finance Bureau 

研究疾病:

胃癌 

Target disease:

gastric 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:

我们旨在探索一种新的胃癌诊断和治疗模式。 

Objectives of Study:

We aimed to explore a new model for the diagnosis and treatment of gastric 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:

整群随机抽样 

Study design:

Cluster randomly sampling 

纳入标准:

2017年7月至2023年12月,采用分组抽样的方式确定胃癌发病率较高的文登区和乳山市的人口,将选区内40-69岁的农村居民纳入筛查范围。所有受试者都同意参与该研究。 

Inclusion criteria

From July 2017 to December 2023, cluster sampling was used to determine the population of the Wendeng District and Rushan City, where the incidence of gastric cancer is high, and rural residents aged 40–69 in the selected area were included in the screening. All the subjects gave their consent to participate in the study. 

排除标准:

患有以下疾病的患者 (1)严重的基础疾病,如心、脑、肺、肝、肾。(2)精神疾病。(3)食道、胃、十二指肠急性穿孔(4)急性/严重喉部疾病(5)食道腐蚀性损伤急性期(6)有凝血功能障碍和(7)其他不适合做胃镜检查的疾病。 

Exclusion criteria:

Patients with: (1) severe basic diseases such as heart, brain, lung, liver and kidney. (2) mental illness. (3) acute perforation of the esophagus, stomach and duodenum (4) acute/severe larynx diseases (5) in the acute stage of corrosive esophageal injury (6) with coagulation dysfunction and (7) with other conditions that are not suitable for gastroscopy. 

研究实施时间:

Study execute time:

From2017-07-01To 2023-12-31 

征募观察对象时间:

Recruiting time:

From2017-07-16To 2023-11-30 

干预措施:

Interventions:

组别:

无分组

样本量:

8000

Group:

No grouping

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):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

威海市立医院 

单位级别:

三甲 

Institution
hospital:

Weihai Municipal Hospital  

Level of the institution:

Triple A Hospitals 

测量指标:

Outcomes:

指标中文名:

胃镜病理

指标类型:

主要指标 

Outcome:

Gastroscopy pathology

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

组织:

Sample Name:

Tissue

Tissue:

stomach

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 69 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):

本研究为胃癌筛查研究,选取的胃癌高发地区的人群为研究对象,并未采用随机方法。

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

This study is a gastric cancer screening study, and the population in the area with high incidence of gastric cancer was selected as the study population, and no randomized method was used.

盲法:

Blinding:

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共享

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

Public accessble via 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:

原始资料由ResMan保管

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

Original documents will be reposed in the assigned persons, and the data will be managed by ResMan.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-19
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