Today is 2020-01-26

Study on intestinal mucosal immunity of IgA nephropathy
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注册号:

Registration number:

ChiCTR1900027959 

最近更新日期:

Date of Last Refreshed on:

2019-12-07 

注册时间:

Date of Registration:

2019-12-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

IgA肾病肠道黏膜免疫的研究 

Public title:

Study on intestinal mucosal immunity of IgA nephropathy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

IgA肾病肠道黏膜免疫的研究 

Scientific title:

Study on intestinal mucosal immunity of IgA nephropathy 

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:

康玉琦 

研究负责人:

曾又佳 

Applicant:

Yuqi Kang 

Study leader:

Youjia Zeng 

申请注册联系人电话:

Applicant telephone:

+86 13570259355 

研究负责人电话:

Study leader's telephone:

+86 0755-82732304 

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:

kangyuqi0203@163.com 

研究负责人电子邮件:

Study leader's E-mail:

kangyuqi0203@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:

深圳市福田区福华路1号 

研究负责人通讯地址:

深圳市福田区福华路1号 

Applicant address:

1 Fuhua Road, Futian District, Shenzhen 

Study leader's address:

1 Fuhua Road, Futian District, Shenzhen 

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:

深圳市中医院 

Applicant's institution:

Shenzhen Hospital of Traditional Chinese Medicine 

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:

K2019-079-01 

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:

深圳市中医院广州中医药大学第四临床医学院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen Traditional Chinese Medicine Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-15 

伦理委员会联系人:

于枫 

Contact Name of the ethic committee:

Feng Yu 

伦理委员会联系地址:

深圳市福田区福华路1号深圳市中医院医技楼八楼 

Contact Address of the ethic committee:

Medical Technology Building, Shenzhen Chinese Medicine Hospital, 1 Fuhua Road, Futian District, Shenzhen. 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0755-88600579 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

szszyyll@126.com 

研究实施负责(组长)单位:

深圳市中医院 

Primary sponsor:

Shenzhen Chinese Medicine Hospital 

研究实施负责(组长)单位地址:

深圳市福田区福华路1号 

Primary sponsor's address:

1 Fuhua Road, Futian District, Shenzhen. 

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):

深圳市中医院

具体地址:

福田区福华路1号

Institution
hospital:

Shenzhen Chinese Medicine Hospital

Address:

1 Fuhua Road, Futian District

经费或物资来源:

自筹 

Source(s) of funding:

Self-raising 

研究疾病:

IgA肾病 

Target disease:

Immunoglobulin A nephropathy 

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:

本研究是为了探寻IgA肾病患者肠道黏膜的淋巴细胞亚群特点,探索IgA肾病上游发病机制,为IgA肾病的治疗寻找潜在靶点。 

Objectives of Study:

This study aims to explore the characteristics of lymphocyte subsets in the intestinal mucosa of patients with IgA nephropathy, explore the pathogenesis of IgA nephropathy, and find potential targets for the treatment of IgA nephropathy. 

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)符合IgA肾病诊断标准的患者; (2)年龄≥18岁、≤70岁; (3)自愿接受试验,并签署知情同意书。 (4)近一个月未使用激素免疫抑制剂,益生菌的患者。 

Inclusion criteria

(1) Patients who meet the diagnostic criteria for IgA nephropathy; (2) Aged >= 18 years and <= 70 years; (3) Voluntarily accept the test and sign the informed consent form. (4) Patients who have not used hormone immunosuppressive agents and probiotics for nearly one month. 

排除标准:

(1)肛门、直肠、或结肠急性或化脓性炎症; (2)严重腹水、孕龄期妇女; (3)急性重症溃疡性结肠炎及疑有中毒性巨结肠者; (4)腹腔慢性炎症至腹腔内广泛粘连; (5)出血性疾病,严重的心肺功能不全及极度衰弱者; (6)急性弥漫性腹膜炎; (7)慢性肾脏病4期和5期的患者; (8)脏器衰竭患者; (9)其他因病情不适合肠镜检查的患者。 

Exclusion criteria:

(1) Acute or purulent inflammation of the anus, rectum, or colon; (2) Severe ascites, women of gestational age; (3) Acute severe ulcerative colitis and suspected toxic megacolon; (4) Chronic inflammation of the abdominal cavity to extensive adhesions in the abdominal cavity; (5) Bleeding disorders, severe cardiopulmonary insufficiency, and extreme debilitation; (6) Acute diffuse peritonitis; (7) Patients with stage 4 and 5 of chronic kidney disease; (8) Patients with organ failure; (9) Other patients who are not suitable for colonoscopy due to their condition. 

研究实施时间:

Study execute time:

From2019-12-13To 2020-09-01 

干预措施:

Interventions:

组别:

试验组

样本量:

40

Group:

experimental group

Sample size:

干预措施:

肠镜

干预措施代码:

Intervention:

Colonoscopy

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):

深圳市中医院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Chinese Medicine Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

CD20

指标类型:

主要指标 

Outcome:

CD20

Type:

Primary indicator 

测量时间点:

测量方法:

免疫荧光

Measure time point of outcome:

Measure method:

Immunofluorescence

指标中文名:

CD27

指标类型:

主要指标 

Outcome:

CD27

Type:

Primary indicator 

测量时间点:

测量方法:

免疫荧光

Measure time point of outcome:

Measure method:

Immunofluorescence

指标中文名:

KM55

指标类型:

主要指标 

Outcome:

KM55

Type:

Primary indicator 

测量时间点:

测量方法:

免疫银光

Measure time point of outcome:

Measure method:

Immunofluorescence

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

回肠末端肠息肉

组织:

回肠末端肠息肉

Sample Name:

Intestinal polyps

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 18 years
最大 Max age 70 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-randomization.

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

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):

ResMan, http://www.medresman.org.cn.

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

ResMan, http://www.medresman.org.cn.

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:

电子采集和管理系统

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

Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-07
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