今天是:2020-08-03 星期一

纸基-ELISA检测人外周血MrgX2受体表达
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注册号:

Registration number:

ChiCTR2000034238 

最近更新日期:

Date of Last Refreshed on:

2020-07-05 

注册时间:

Date of Registration:

2020-06-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

纸基-ELISA检测人外周血MrgX2受体表达 

Public title:

The expression of MrgX2 receptor in human peripheral blood detected by paper-based ELISA 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一种快速、灵敏、定量检测类过敏反应相关MrgX2的纸基ELISA方法 

Scientific title:

A new paper-based ELISA approach for rapid, sensitive and quantitative detection of anaphylaxis related MrgX2 

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:

孔利云 

研究负责人:

孔利云 

Applicant:

Liyun Kong 

Study leader:

Liyun Kong 

申请注册联系人电话:

Applicant telephone:

+86 15702990201 

研究负责人电话:

Study leader's telephone:

+86 15702990201 

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:

kongly@xjtu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

kongly@xjtu.edu.cn 

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:

陕西省西安市雁塔区雁塔西路76号交大医学部 

研究负责人通讯地址:

陕西省西安市雁塔区雁塔西路76号 

Applicant address:

76 Yanta Road West, Yanta District, Xi'an, Shaanxi, China 

Study leader's address:

76 Yanta Road West, Yanta District, Xi'an, Shaanxi, China 

申请注册联系人邮政编码:

Applicant postcode:

710061 

研究负责人邮政编码:

Study leader's postcode:

710061 

申请人所在单位:

西安交通大学 

Applicant's institution:

Xi'an Jiaotong 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:

2020-1246 

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:

西安交通大学医学部生物医学伦理委员会 

Name of the ethic committee:

Biomedical Ethics Committee of Health Science Center, Xi'an Jiaotong University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-28 

伦理委员会联系人:

陈腾 

Contact Name of the ethic committee:

Teng Chen 

伦理委员会联系地址:

陕西省西安市雁塔区雁塔西路76号交大医学部 

Contact Address of the ethic committee:

Xi'an Jiaotong University Health Science Center, 76 Yanta Road West, Yanta District, Xi'an, Shaanxi, 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:

西安交通大学 

Primary sponsor:

Xi'an Jiaotong University 

研究实施负责(组长)单位地址:

陕西省西安市雁塔区雁塔西路76号交大医学部 

Primary sponsor's address:

76 Yanta Road West, Yanta District, Xi'an, Shaanxi, 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):

陕西

市(区县):

西安

Country:

China

Province:

Shaanxi

City:

Xi'an

单位(医院):

西安交通大学

具体地址:

陕西省西安市雁塔区雁塔西路76号交大医学部

Institution
hospital:

Xi'an Jiaotong University

Address:

76 Yanta Road West, Yanta District

国家:

中国

省(直辖市):

陕西

市(区县):

西安

Country:

China

Province:

Shaanxi

City:

Xi'an

单位(医院):

西安交通大学第二附属医院

具体地址:

陕西省西安市西五路157号

Institution
hospital:

The Second Affiliated Hospital of Xi'an Jiaotong University

Address:

157 Xiwu Road, Xi'an, Shaanxi

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

Natural Science Foundation of China 

研究疾病:

不适用 

Target disease:

N/A 

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:

其它 

Study phase:

N/A 

研究目的:

(1)利用建立的纸基-ELISA试剂盒检测人外周血MrgX2蛋白的表达水平; (2)评判纸基-ELISA试剂盒在人外周血及相关疾病的应用。 

Objectives of Study:

(1) Use the established paper-based ELISA kit to detect the expression level of MrgX2 protein in human peripheral blood;(2) Judge the application of paper-based ELISA kit in human peripheral blood and related diseases. 

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:

(1)年龄范围为6-80岁; (2)近期内无其他疾病; (3)自愿参加本项目并能够按要求执行者; (4)已签署知情同意书,并能够按要求完成者。 

Inclusion criteria

(1) Aged 6-80 years old; (2) No other diseases in the near future; (3) Those who voluntarily participate in this project and can perform as required; (4) Those who have signed the informed consent and can complete it as required. 

排除标准:

(1)有明确急性感染指征患者; (2)无法合作或不能坚持治疗、预知依从性差的患者; (3)孕妇及哺乳期妇女; (4)患者同时正参加其他临床试验研究。 

Exclusion criteria:

(1) Patients with clear indications of acute infection; (2) Patients who are unable to cooperate or cannot adhere to treatment and predict poor compliance; (3) Pregnant women and lactating women; (4) The patient is also participating in other clinical trials. 

研究实施时间:

Study execute time:

From2020-06-28To 2020-07-10 

征募观察对象时间:

Recruiting time:

From2020-06-28To 2020-07-10 

干预措施:

Interventions:

组别:

随机取样组

样本量:

18

Group:

Case series

Sample size:

干预措施:

不适用

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西省 

市(区县):

西安 

Country:

China 

Province:

Shaanxi 

City:

xi'an 

单位(医院):

西安交通大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Xi'an Jiaotong University  

Level of the institution:

Tertiary A hospital  

测量指标:

Outcomes:

指标中文名:

MrgX2蛋白水平

指标类型:

主要指标 

Outcome:

MrgX2 protein level

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:

抗凝外周血

组织:

Sample Name:

Anticoagulation of peripheral blood

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 6 years
最大 Max age 80 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):

不适用

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

N/A

盲法:

N/A

Blinding:

N/A

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):

不适用

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

N/A

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:

以CRF为数据采集和管理依据

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-06-29
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