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消化道肿瘤患者基因表达研究
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注册号:

Registration number:

ChiCTR1900026337 

最近更新日期:

Date of Last Refreshed on:

2019-09-30 

注册时间:

Date of Registration:

2019-09-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

消化道肿瘤患者基因表达研究 

Public title:

Gene expression in patients with gastrointestinal cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

消化道肿瘤患者基因表达研究 

Scientific title:

Gene expression in patients with gastrointestinal cancer 

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:

节梦梦 

研究负责人:

胡长江 

Applicant:

Mengmeng Jie 

Study leader:

Changjiang Hu 

申请注册联系人电话:

Applicant telephone:

+86 15683418232 

研究负责人电话:

Study leader's telephone:

+86 13677683069 

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:

jmm_416@126.com 

研究负责人电子邮件:

Study leader's E-mail:

chu2@bidmc.harvard.edu 

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:

中国重庆市沙坪坝区新桥正街183号 

研究负责人通讯地址:

中国重庆市沙坪坝区新桥正街183号 

Applicant address:

183 Xinqiao Main Street, Shapingba District, Chongqing, China 

Study leader's address:

183 Xinqiao Main Street, Shapingba District, Chongqing, 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:

中国人民解放军第三军医大学第二附属医院消化科 

Applicant's institution:

Department of Gastroenterology, Xinqiao Hospital, the Third Military 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:

YB M-05-02 

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:

上海芯超生物科技有限公司伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Outdo Biotech Company 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-07-03 

伦理委员会联系人:

陈文明 

Contact Name of the ethic committee:

Wenming Chen 

伦理委员会联系地址:

上海市浦东新区张江高科技园区李冰路151号 

Contact Address of the ethic committee:

151 Libing Road, Zhangjiang High-Tech Park, Pudong New Area, 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:

中国人民解放军第三军医大学第二附属医院 

Primary sponsor:

Xinqiao Hospital, the Third Military Medical University 

研究实施负责(组长)单位地址:

中国重庆市沙坪坝区新桥正街183号 

Primary sponsor's address:

183 Xinqiao Main Street, Shapingba District, Chongqing, 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):

重庆市

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

中国人民解放军第三军医大学第二附属医院

具体地址:

沙坪坝区新桥正街183号

Institution
hospital:

Xinqiao Hospital, the Third Military Medical University

Address:

183 Xinqiao Main Street, Shapingba District

经费或物资来源:

NSFC 

Source(s) of funding:

NSFC 

研究疾病:

消化道肿瘤 

Target disease:

gastrointestinal cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

(1) 明确相关基因表达水平与消化道肿瘤患者的临床病理特征及预后的相关性; (2) 明确相关基因表达变化对消化道肿瘤的调控作用。 

Objectives of Study:

(1) To clarify the correlation between the expression level of related genes and the clinicopathological characteristics and prognosis of patients with digestive tract tumors; (2) To clarify the regulatory role of related gene expression changes in digestive tract tumors. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1. 年龄≥18岁,且≤85岁; 2. 住院病例,男女不限; 3. 明确诊断为消化道肿瘤的病人; 4. 签署知情同意书 

Inclusion criteria

1. aged from 18 to 85 years; 2. inpatient,male or female; 3. patients diagnosed with gastrointestinal cancer; 4. Sign the informed consent.  

排除标准:

1. 妊娠及哺乳期妇女; 2. 综合判断依从性较差的病例。 

Exclusion criteria:

1. pregnant and lactating women; 2. patients with poor compliance. 

研究实施时间:

Study execute time:

From2019-09-17To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2019-09-17To 2021-12-31 

干预措施:

Interventions:

组别:

肿瘤组

样本量:

180

Group:

gastrointestinal cancer

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

组别:

癌旁组

样本量:

180

Group:

NC

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

中国人民解放军第三军医大学第二附属医院 

单位级别:

三甲 

Institution
hospital:

Xinqiao Hospital, the Third Military Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

基因表达

指标类型:

主要指标 

Outcome:

gene expression

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:

癌和癌旁组织

组织:

Sample Name:

cancer tissues and paracancer tissues

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

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):

通过网络平台共享

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

Six months after the end of the trial, use chictr.org.cn platform open

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:

采用Excel表格及图表方式

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

the Excel was used to save data

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-09-30
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