今天是:2020-08-03 星期一

慢性前列腺炎患者体内炎症介质及白细胞分化抗原表达状况的研究
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注册号:

Registration number:

ChiCTR2000034396 

最近更新日期:

Date of Last Refreshed on:

2020-07-04 

注册时间:

Date of Registration:

2020-07-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

慢性前列腺炎患者体内炎症介质及白细胞分化抗原表达状况的研究 

Public title:

Diferential expression of immune factor and CD molecule between patients with chronic prostatitis and the healthy volunteers 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

慢性前列腺炎患者体内炎症介质及白细胞分化抗原表达状况的研究 

Scientific title:

Differential expression of immune factor and CD molecule between patients with chronic prostatitis and the healthy volunteers 

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:

彭绪峰 

研究负责人:

彭绪峰 

Applicant:

Peng Xufeng 

Study leader:

Peng Xufeng 

申请注册联系人电话:

Applicant telephone:

+86 19916546074 

研究负责人电话:

Study leader's telephone:

+86 19916546074 

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:

pxf1991715@163.com 

研究负责人电子邮件:

Study leader's E-mail:

pxf1991715@163.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:

上海市徐汇区宜山路600号 

研究负责人通讯地址:

上海市徐汇区宜山路600号 

Applicant address:

600 Yishan Road, Xuhui District, Shanghai, China 

Study leader's address:

600 Yishan Road, Xuhui District, Shanghai, 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:

上海交通大学附属上海市第六人民医院 

Applicant's institution:

Shanghai Jiaotong University Affiliated Sixth People's 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:

2020-61-7 

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:

上海市第六人民医院伦理委员会 

Name of the ethic committee:

Ethic Committee of Shanghai Sixth People's Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-07 

伦理委员会联系人:

孙秀秀 

Contact Name of the ethic committee:

Xiuxiu Sun 

伦理委员会联系地址:

上海市宜山路600号 

Contact Address of the ethic committee:

600 Yishan Road, Xuhui District, Shanghai, 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:

上海交通大学附属上海市第六人民医院 

Primary sponsor:

Shanghai Jiaotong University Affiliated Sixth People's Hospital 

研究实施负责(组长)单位地址:

上海市徐汇区宜山路600号上海市第六人民医院 

Primary sponsor's address:

600 Yishan Road, Xuhui District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学附属上海市第六人民医院

具体地址:

徐汇区宜山路600号

Institution
hospital:

Shanghai Jiaotong University Affiliated Sixth People's Hospital

Address:

600 Yishan Road, Xuhui District

经费或物资来源:

自筹 

Source(s) of funding:

Self-Funding 

研究疾病:

慢性前列腺炎 

Target disease:

chronic prostatitis 

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:

比较不同类别慢性前列腺炎及正常人之间炎症介质及白细胞分化抗原的差异。 

Objectives of Study:

To compare the differential expression of immune factor and CD molecule between patients with chronic prostatitis and the healthy volunteers. 

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确诊为慢性前列腺炎的男性患者将被包括在内(参照美国国立卫生研究院关于慢性前列腺炎的专家诊疗共识制定的诊断标准); ②患者年龄18~60岁; ③自愿参加本研究者; ④患者知情同意。 

Inclusion criteria

1. Male patients diagnosed with Chronic prostatitis will be included (refer to the National Institutes of Health diagnostic criteria for the diagnosis and treatment of Chronic prostatitis); 2. Patient aged 18 to 60 years old; 3. Voluntary Participants in the study; 4. Patients informed consent.  

排除标准:

① 盆腔手术史或6个月内者; ② 并发泌尿生殖系统发育异常或感染者; ③ 前列腺结核、良性前列腺增生和前列腺癌、急性尿道综合征者; ④ 伴有严重的躯体疾病、全身衰竭,以及对坦索罗辛药过敏者; ⑤ 在治疗前2周服用其他治疗前列腺疾病药物患者。 对于以上 5 项排除标准,只要有1项满足即为符合排除标准,需要排除。 

Exclusion criteria:

1. pelvic surgery history or within 6 months; 2. complicated by genitourinary dysplasia or infection; 3. prostate tuberculosis, benign prostatic hyperplasia and prostate cancer, acute urethral syndrome; 4. with serious Physical illness, systemic failure, and allergy to tamsulosin; 5. patients taking other drugs for prostate disease 2 weeks before treatment. For the above 5 exclusion criteria, as long as one of the criteria is met, the exclusion criteria are met and need to be excluded.  

研究实施时间:

Study execute time:

From2020-07-04To 2021-02-27 

征募观察对象时间:

Recruiting time:

From2020-07-04To 2021-02-27 

干预措施:

Interventions:

组别:

慢性细菌性前列腺炎组

样本量:

45

Group:

chronic bacterial prostatitis group

Sample size:

干预措施:

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

慢性非细菌性前列腺炎组

样本量:

45

Group:

chronic abacterial prostatitis group

Sample size:

干预措施:

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

健康自愿者组

样本量:

30

Group:

Healthy volunteers group

Sample size:

干预措施:

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学附属上海市第六人民医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Jiaotong University Affiliated Sixth People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

NIH-CPSI评分

指标类型:

主要指标 

Outcome:

The NIH - CPSI score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

前列腺超声

指标类型:

主要指标 

Outcome:

Ultrasonography of prostate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

前列腺液

指标类型:

主要指标 

Outcome:

prostatic fluid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

主要指标 

Outcome:

routine urine test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症介质检查

指标类型:

主要指标 

Outcome:

Inflammatory mediators examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD分子检测

指标类型:

主要指标 

Outcome:

CD molecular detection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

主要指标 

Outcome:

c-reactive protein

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:

尿液

组织:

Sample Name:

urine

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:

标本中文名:

前列腺液

组织:

Sample Name:

前列腺液

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 18 years
最大 Max age 60 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):

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):

试验完成后六月内公开原始数据,临床试验实时数据库

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

publication of the original data when the trial complete after six months; electronic case record form system

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:

临床试验实时数据库

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

electronic case record form system

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-07-04
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