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Large-scale application and diagnostic value evaluation of a gastric cancer screening model: a nationwide cross-sectional study
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注册号:

Registration number:

ChiCTR2200060018 

最近更新日期:

Date of Last Refreshed on:

2022-05-15 

注册时间:

Date of Registration:

2022-05-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请核对伦理批件有效期,如已过期请重新申请或申请延期,请与我们联系完善试验主办单位信息,并核对干预措施信息。 胃癌筛查模型的大规模应用和诊断价值评估:一项全国性横断面研究 

Public title:

Large-scale application and diagnostic value evaluation of a gastric cancer screening model: a nationwide cross-sectional study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国无症状人群胃癌筛查新策略推广应用 

Scientific title:

New strategy of gastric cancer screening for asymptomatic individuals in China 

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:

周显祝 

研究负责人:

杜奕奇 

Applicant:

Zhou xianzhu 

Study leader:

Du yiqi 

申请注册联系人电话:

Applicant telephone:

+86 18521945318 

研究负责人电话:

Study leader's telephone:

+8621-31161344 

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:

zhouxianzhu1994@163.com 

研究负责人电子邮件:

Study leader's E-mail:

duyiqi@hotmail.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:

上海市长海医院 

研究负责人通讯地址:

上海市长海医院 

Applicant address:

Changhai Hospital, Naval Medical University, 168 Changhai Road 

Study leader's address:

Changhai Hospital, Naval Medical University, 168 Changhai Road 

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:

上海市长海医院 

Applicant's institution:

Changhai Hospital, Naval Medical University 

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:

CHEC2018-169 

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:

上海长海医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Changhai Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

张优琴 

Contact Name of the ethic committee:

Zhang Youqin 

伦理委员会联系地址:

上海杨浦区长海路174号 

Contact Address of the ethic committee:

174 Changhai Road, Yangpu 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:

长海医院 

Primary sponsor:

Changhai Hospital 

研究实施负责(组长)单位地址:

上海杨浦区长海路174号 

Primary sponsor's address:

174 Changhai Road, Yangpu District, Shanghai  

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

self-funded 

研究疾病:

胃癌 

Target disease:

gastric cancer 

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:

其它 

Study phase:

N/A 

研究目的:

在全国地区无症状人群中推广应用李氏胃癌筛查方案,评估李氏胃癌筛查模型的区分度和校准度 

Objectives of Study:

Promoting the application of the Lee's gastric cancer screening model in an asymptomatic population in a national region and assessing the discrimination and calibration of the Lee's gastric cancer screening 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:

连续入组 

Study design:

Sequential 

纳入标准:

年龄40~79岁的无消化道症状人群,性别不限,需签署知情同意。 

Inclusion criteria

People aged 40 to 79 years without gastrointestinal symptoms, regardless of gender, are required to sign informed consent. 

排除标准:

排除标准(下列任意一条符合即排除):A距上次胃镜检查间隔时间一年内;B胃大部切除术手术史;C两周内服用PPI(埃索美拉唑、泮托拉唑、雷贝拉唑、兰索拉唑等)或H2受体拮抗剂(法莫替丁等);D有下列一种或多种症状:6个月内缺铁性贫血;12个月内消化道出血(黑便、血便等);体重减轻(非减肥原因6个月内体重减轻≥4.5Kg);经常性腹泻;吞咽困难或哽噎感;腹部肿块。E有以下任何一种疾病史:食管癌、胃癌、结直肠肿瘤、息肉病、炎症性肠病、其它器官恶性肿瘤(乳腺、卵巢、子宫及泌尿系统等);F影像、肿瘤标志物等检查高度怀疑罹患肿瘤可能;G严重心、肺、肝、肾功能不全,或严重精神疾患 

Exclusion criteria:

Exclusion criteria (excluded if any of the following are met): A within one year from the last gastroscopy; B with a history of major gastrectomy surgery; C taking a PPI (esomeprazole, pantoprazole, rabeprazole, lansoprazole, etc.) or H2 receptor antagonist (famotidine, etc.) within two weeks. D A history of one or more of the following: iron deficiency anemia within 6 months; gastrointestinal bleeding (black stools, bloody stools, etc.) within 12 months; weight loss (≥4.5 Kg within 6 months); frequent diarrhea; dysphagia or choking sensation; abdominal masses. E history of any of the following diseases: esophageal cancer, gastric cancer, colorectal tumor, polyposis, inflammatory bowel disease, malignant tumor of other organs (breast, ovary, uterus and urinary system, etc.); F imaging and tumor marker tests with high suspicion of tumor; G severe cardiac, pulmonary, hepatic and renal insufficiency, or severe mental illness 

研究实施时间:

Study execute time:

From2022-05-04To 2022-12-29 

征募观察对象时间:

Recruiting time:

From2022-05-04To 2022-12-29 

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):

胃镜和胶囊内镜

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):

Gastroscope and capsule endoscopy

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):

李氏胃癌筛查评分系统(问卷调查、血清胃蛋白酶原、胃泌素-17、幽门螺杆菌抗体检测)

Index test:

Li's gastric cancer screening scoring system(Questionnaire survey, detection of serum pepsinogen, gastrin-17 and Helicobacter pylori antibody)

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)

无症状社区人群

例数:

Sample size:

0

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):

Asymptomatic community population

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:

None

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

长海医院 

单位级别:

三甲 

Institution
hospital:

Changhai hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

胃蛋白酶原I

指标类型:

主要指标 

Outcome:

PGI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃蛋白酶原II

指标类型:

主要指标 

Outcome:

PG2

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃泌素17

指标类型:

主要指标 

Outcome:

G-17

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

幽门螺杆菌抗体

指标类型:

主要指标 

Outcome:

Anti-H. pylori IgG

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:

标本中文名:

胃粘膜

组织:

Sample Name:

gastric mucosa

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

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

NA

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):

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:

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:

有/Yes

注册人:

Name of Registration:

 2022-05-15
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