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胃癌高发区人群根除幽门螺杆菌感染预防胃癌的干预研究-内窥镜随访研究
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注册号:

Registration number:

ChiCTR1900022849 

最近更新日期:

Date of Last Refreshed on:

2019-04-28 

注册时间:

Date of Registration:

2019-04-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

胃癌高发区人群根除幽门螺杆菌感染预防胃癌的干预研究-内窥镜随访研究 

Public title:

A randomized, controlled intervention trial for prevent gastric cancer by eradication of Helicobacter pylori in Linqu County, China: Endoscopy Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

胃癌高发区人群根除幽门螺杆菌感染预防胃癌的干预研究-内窥镜随访研究 

Scientific title:

A randomized, controlled intervention trial for prevent gastric cancer by eradication of Helicobacter pylori in Linqu County, China: Endoscopy Trial 

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:

李哲轩 

研究负责人:

潘凯枫 

Applicant:

Zhexuan Li 

Study leader:

Kaifeng Pan 

申请注册联系人电话:

Applicant telephone:

+86 010-88196761 

研究负责人电话:

Study leader's telephone:

+86 010-88196937 

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:

zhexuanli@bjmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

pan-kf@263.net 

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:

北京市海淀区阜成路52号,北京大学肿瘤医院,科研楼511室 

研究负责人通讯地址:

北京市海淀区阜成路52号,北京大学肿瘤医院,科研楼507室 

Applicant address:

52 Fucheng Road, Haidian District, Beijing, China  

Study leader's address:

52 Fucheng Road, Haidian 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:

北京肿瘤医院/北京大学肿瘤医院/北京市肿瘤防治研究所 

Applicant's institution:

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing Institute for Cancer Research  

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:

2018KT113 

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:

北京肿瘤医院医学伦理委员会 

Name of the ethic committee:

Institutional Review Board (IRB) of Peking University Cancer Hospital & Institute  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-10 

伦理委员会联系人:

周连顺 

Contact Name of the ethic committee:

Lianshun Zhou 

伦理委员会联系地址:

北京市海淀区阜成路81号 

Contact Address of the ethic committee:

81 Fucheng Road, Haidian 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:

北京大学肿瘤医院,北京市肿瘤防治研究所 

Primary sponsor:

Peking University Cancer Hospital & Institute, Beijing Institute for Cancer Research  

研究实施负责(组长)单位地址:

北京市海淀区阜成路52号 

Primary sponsor's address:

52 Fucheng Road, Haidian 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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学肿瘤医院, 北京市肿瘤防治研究所

具体地址:

海淀区阜成路52号

Institution
hospital:

Peking University Cancer Hospital & Institute, Beijing Institute for Cancer Research

Address:

52 Fucheng Road, Haidian District

国家:

德国

省(直辖市):

巴伐利亚州

市(区县):

慕尼黑

Country:

Germany

Province:

Free State of Bavaria

City:

Munich

单位(医院):

慕尼黑工业大学

具体地址:

Arcisstrabe 21, 80333 München

Institution
hospital:

Technische Universitat München

Address:

Arcisstrabe 21, 80333 München

经费或物资来源:

国家自然基金委基金项目及国际合作项目 

Source(s) of funding:

Fundings from National Natural Science Foundation of China 

研究疾病:

胃癌及胃黏膜癌前病变 

Target disease:

Gastric cancer and precancerous gastric lesions 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究拟对根除H. pylori预防胃癌干预队列人群进行定期胃镜随访,并采集生物学样本进行形态学、分子生物学分析,探索根除H. pylori对机体及胃黏膜病变影响的分子机制,将能够为个体化分级预防和干预策略提供重要的科学依据。 

Objectives of Study:

The planned study is an important next step after the ongoing Large-Linqu-Trial, addressing histopathologic, serologic and molecular biomarkers for assessment of GC risk.  

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. 参加者自愿参加本健康项目,并签属知情同意书。 2. 男性或非孕期、非哺乳期女性临朐县居民。 3. 年龄40-69岁。 

Inclusion criteria

1. Male or non-pregnant, non-nursing female participants will be eligible. 2. The age limits are 40–69 years. 3. Subjects must sign an informed consent form (ICF) and receive a questionnaire interview. 

排除标准:

1. 消化道溃疡患者; 2. 正进行严重疾病的治疗,可能妨碍参加研究者; 3. 正进行肿瘤的治疗; 4. 现在或曾经进行抗Hp治疗者; 5. 充血性心力衰竭病史; 6. 呼吸衰竭; 7. 中风、癫痫、痴呆; 8. 精神类疾病; 9. 酗酒和药物滥用者; 10. 有甲硝唑、四环素或奥美拉唑服用禁忌症者; 11. 肾功能不全病史(肾小球滤过率< 50%); 12. 有胃黏膜活检禁忌症者(如凝血障碍)。 

Exclusion criteria:

1. Peptic ulcers; 2. Being treated for serious medical condition which could hinder participation; 3. Undergoing active treatment for cancer; 4. Current or previous antibiotic therapy for H. pylori infection; 5. History of congestive heart failure; 6. Respiratory failure; 7. Stroke, seizures, dementia; 8. Psychiatric illness; 9. Alcoholism or drug abuse; 10. Presence of a contraindication to the use of metronidazole, tetracycline or omeprazole; 11. Family history of GC in a first degree relative; 12. History of severe impaired renal function (GFR < 50%); 13. Contraindication for biopsy sampling (e.g. comprised plasmatic or cellular blood clotting).  

研究实施时间:

Study execute time:

From2019-05-01To 2029-05-01 

干预措施:

Interventions:

组别:

干预组

样本量:

4500

Group:

Intervention group

Sample size:

干预措施:

幽门螺杆菌根除治疗

干预措施代码:

Intervention:

H.pylori eradication therapy

Intervention code:

组别:

安慰剂对照组

样本量:

4500

Group:

Placebo group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

阴性随访组

样本量:

1000

Group:

H.pylori negative follow-up group

Sample size:

干预措施:

自然胃镜随访

干预措施代码:

Intervention:

follow-up

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):

临朐县 

Country:

China 

Province:

Shandong 

City:

Linqu County 

单位(医院):

临朐县人民医院 

单位级别:

二级甲等 

Institution
hospital:

Peoples' hospital of Linqu county  

Level of the institution:

Secondary A 

测量指标:

Outcomes:

指标中文名:

幽门螺杆菌感染状态

指标类型:

主要指标 

Outcome:

H.pylori infection status

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃黏膜病理诊断

指标类型:

主要指标 

Outcome:

pathology diagnosis of gastric biopsy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃癌血清标志物

指标类型:

次要指标 

Outcome:

biomarkers for gastric cancer

Type:

Secondary 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:

胃黏膜活检组织

组织:

胃黏膜

Sample Name:

Biopsy of gastric mucousa

Tissue:

gastric mucousa

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:

呼气

组织:

Sample Name:

Exhaled air

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 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):

独立统计学家以完全随机化设计的方法由计算机软件生成随机码。

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

Independent statistician from TUM will generate intervention code by simple randomization procedure.

盲法:

随机化结果将对研究者和受试对象实施盲法。为避免在研究过程中露盲,干预药物将使用6个编码(每个干预方案3个)。

Blinding:

The randomized trial will be double-blinded with neither the subjects nor investigators told the identity of the intervention assignments. To reduce the chance of unmasking the treatment regimen, 6 different codes (3 for each group) will be used to label the treatment drug packages

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验结果公开发表,原始数据暂不公开

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

Data will be published after the trial

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:

调查问卷及体格检查数据采用自行研发的电子化数据采集平台采集数据 电子化数据及记录使用Access或SQL数据库软件保存管理及使用

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

Electronic data set by Access or SQL for data analysis and electronic questionnaires for archiving

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-28
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