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Strongyloides stercoralis screening for patients on immunosuppression
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注册号:

Registration number:

ChiCTR2100052204 

最近更新日期:

Date of Last Refreshed on:

2022-04-21 

注册时间:

Date of Registration:

2021-10-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

免疫抑制治疗病人的粪类圆线虫病筛查 

Public title:

Strongyloides stercoralis screening for patients on immunosuppression 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

免疫抑制治疗病人的粪类圆线虫病筛查 

Scientific title:

Strongyloides stercoralis screening for patients on immunosuppression 

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:

叶海燕 

研究负责人:

叶海燕 

Applicant:

Ye Haiyan 

Study leader:

Ye Haiyan 

申请注册联系人电话:

Applicant telephone:

+86 15986707186 

研究负责人电话:

Study leader's telephone:

+86 15986707186 

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:

yehy@hku-szh.org 

研究负责人电子邮件:

Study leader's E-mail:

yehy@hku-szh.org 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www.hku-szh.org 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www.hku-szh.org 

申请注册联系人通讯地址:

广东省深圳市福田区海园一路1号 

研究负责人通讯地址:

广东省深圳市福田区海园一路1号 

Applicant address:

1 1st Haiyuan Road, Futian District, Shenzhen, Guangdong 

Study leader's address:

1 1st Haiyuan Road, Futian District, Shenzhen, Guangdong 

申请注册联系人邮政编码:

Applicant postcode:

518000 

研究负责人邮政编码:

Study leader's postcode:

518000 

申请人所在单位:

香港大学深圳医院 

Applicant's institution:

The University of Hong Kong-Shenzhen Hospital 

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:

伦[2019]090 

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:

香港大学深圳医院医学研究伦理委员会 

Name of the ethic committee:

Research Ethics Committee of the University of Hong Kong-Shenzhen Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-26 

伦理委员会联系人:

王静贤 

Contact Name of the ethic committee:

Wang Jingxian 

伦理委员会联系地址:

广东省深圳市福田区海园一路1号 

Contact Address of the ethic committee:

1 1st Haiyuan Road, Futian District, Shenzhen, Guangdong 

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:

香港大学深圳医院 

Primary sponsor:

The University of Hong Kong-Shenzhen Hospital 

研究实施负责(组长)单位地址:

广东省深圳市福田区海园一路1号 

Primary sponsor's address:

1 1st Haiyuan Road, Futian District, Shenzhen, Guangdong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

香港大学深圳医院

具体地址:

福田区海园一路1号

Institution
hospital:

The University of Hong Kong-Shenzhen Hospital

Address:

1 1st Haiyuan Road, Futian District

经费或物资来源:

深圳市三名工程 

Source(s) of funding:

Shenzhen '' Sanming'' Project 

研究疾病:

粪类圆线虫病 

Target disease:

Strongyloides stercoralis 

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:

1.建立一种对免疫抑制患者进行粪类圆线虫病筛查的方法。 2.了解粪类圆线虫病在免疫抑制患者中的患病率,并筛选其他易感因素。 3.提高医务人员对粪类圆线虫病的认识和诊治能力,降低粪类圆线虫病高危人群的死亡率。 

Objectives of Study:

1. To establish a screening method for strongyliasis faecalis in immunosuppressed patients. 2. To understand the prevalence of strongyliasis faecalis in immunosuppressed patients and screen for other susceptible factors. 3. To improve the medical staff's knowledge of strongyliasis faecalis and their ability of diagnosis and treatment, and to reduce the mortality rate of strongyliasis faecalis high-risk groups. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

有流行病学暴露史如赤脚农田耕作业史、流行地区旅行居住史、以及粪类圆线虫病人的粪便接触史。 

Inclusion criteria

History of epidemiological exposure such as barefoot farming, travel and residence in endemic areas, and fecal exposure of strongyloidiasis patients. 

排除标准:

无 

Exclusion criteria:

None 

研究实施时间:

Study execute time:

From2021-11-01To 2023-10-31 

征募观察对象时间:

Recruiting time:

From2021-11-01To 2023-10-31 

干预措施:

Interventions:

组别:

连续入组

样本量:

200

Group:

Case series

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):

广东 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

香港大学深圳医院 

单位级别:

三甲 

Institution
hospital:

The University of Hong Kong-Shenzhen Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

粪类圆线虫病的感染率

指标类型:

主要指标 

Outcome:

The infection rate of strongyliasis faecalis

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:

粪便

组织:

Sample Name:

stool

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:

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:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet 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):

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

no

盲法:

Blinding:

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):

no

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:

采用病例记录表方式,电子保存在本科室电脑。

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

The form of case record is kept electronically in the computer of our department.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-10-22
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