今天是:2019-05-24 星期五

一项关于HLA等位基因在儿童激素依赖/频复发肾病综合征作用的回顾性队列研究
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注册号:

Registration number:

ChiCTR1900023187 

最近更新日期:

Date of Last Refreshed on:

2019-05-15 

注册时间:

Date of Registration:

2019-05-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项关于HLA等位基因在儿童激素依赖/频复发肾病综合征作用的回顾性队列研究  

Public title:

A retrospective cohort study for the role of HLA alleles in steroid-dependent/recurrent nephrotic syndrome in children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项关于HLA等位基因在儿童激素依赖/频复发肾病综合征作用的回顾性队列研究 

Scientific title:

A retrospective cohort study for the role of HLA alleles in steroid-dependent/recurrent nephrotic syndrome in children 

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:

李秋 

研究负责人:

阳海平 

Applicant:

Qiu Li 

Study leader:

Haiping Yang 

申请注册联系人电话:

Applicant telephone:

+86 15215150041 

研究负责人电话:

Study leader's telephone:

+86 15215150041 

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:

liqiu809@126.com 

研究负责人电子邮件:

Study leader's E-mail:

liqiu809@126.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:

重庆市渝中区中山二路136号 

研究负责人通讯地址:

重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China  

Study leader's address:

136 Second Zhongshan Road, Yuzhong 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:

重庆医科大学附属儿童医院肾脏内科,教育部重点实验室  

Applicant's institution:

Children's Hospital of Chongqing 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:

2019-21 

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:

重庆医科大学附属儿童医院伦理审查委员会 

Name of the ethic committee:

Ethics Committee of Children's Hospital of Chongqing Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-30 

伦理委员会联系人:

卢仲毅 

Contact Name of the ethic committee:

Zhongyi Lu 

伦理委员会联系地址:

重庆市渝中区中山二路136号 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属儿童医院肾脏内科 

Primary sponsor:

Children's Hospital of Chongqing Medical University  

研究实施负责(组长)单位地址:

重庆渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong 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(区县):

重庆

Country:

China

Province:

Chongqing

City:

Chongqing

单位(医院):

重庆医科大学附属儿童医院

具体地址:

渝中区中山二路136号

Institution
hospital:

Children's Hospital of Chongqing Medical University

Address:

136 Second Zhongshan Road, Yuzhong District

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Fund  

研究疾病:

原发性肾病综合征 

Target disease:

Primary Nephrotic Syndrome  

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)SSNS与SDNS/FRNS的HLA等位基因频率差异性分析; 2)SSNS与SDNS/FRNS相比,复发次数、频率、激素、免疫抑制剂与HLA等位基因频率差异性分析; 3)SSNS、SDNS/FRNS患者预后分析。 

Objectives of Study:

1) frequency difference analysis of HLA allele between SSNS and SDNS/FRNS; 2) compared with SDNS/FRNS, the frequency, recurrence frequency, hormone, immunosuppressant and HLA allele frequency of SSNS were analyzed; 3) prognostic analysis of SSNS and SDNS/FRNS patients. 

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)起病年龄半岁至18岁且我院随访3年以上; (2)原发性肾病综合征(primary nephrotic syndrome, PNS),其诊断标准:大量蛋白尿:24h 蛋白尿定量≧50mg/kg 或晨尿蛋白/肌酐(mg/mg)≧2.0,1 周 3 次晨尿蛋白定性(+++-++++);低蛋白血症:血清白蛋白低于 25g/L;高脂血症:血清胆固醇高于 5.7mmol/L;不同程度的水肿。以上 4 项中以 1 和 2 为诊断的必要条件; (3)激素敏感型NS:以泼尼松足量 2mg/(kg.d)或 60mg/(m2.d)治疗≤4 周尿蛋白转阴者,门诊随访3年以上为复发者。 激素依赖型/频复发NS:对激素敏感,但连续两次减量或停药 2 周内复发者,同时满足指病程中半年内复发≥2次,或1年内复发≥4次。SSNS注意排除随访过程中有迟发型SRNS。 

Inclusion criteria

(1) the onset age was from half a year to 18 years old, and the follow-up of our hospital was more than 3 years; (2) primary nephrotic syndrome (PNS), diagnostic criteria: quantitative 50mg/kg of proteinuria at 24h, or quantitative 50mg/kg of morning urine protein/creatinine (mg/mg) 2.0, 3 times a week (+++-++++ +). Hypoproteinemia: serum albumin is less than 25g/L; Hyperlipidemia: serum cholesterol was higher than 5.7mmol/L.Varying degrees of edema. In the above four items, 1 and 2 are the necessary conditions for diagnosis; (3) Hormone-sensitive NS: patients treated with prednisone at 2mg/(kg.d) or 60mg/(mm2.D) for less than 4 weeks of urine protein negative conversion were followed up for more than 3 years for recurrence. Steroid-dependent/recurrent NS: sensitive to hormones, but with two consecutive dose reduction or drug withdrawal within 2 weeks of recurrence, the duration of the disease shall be no less than 2 times of recurrence within half a year, or no less than 4 times of recurrence within 1 year.SSNS noted that delayed SRNS was excluded during follow-up. 

排除标准:

(1)排除激素副反应明显、不能耐受激素或有激素禁忌症患者。 (2)除外肾炎型肾病综合征(nephritic-nephrotic syndrome,NNS),即具有以下四项之一或多项者: ① 2周内分别3次离心尿镜检红细胞≥10个/高倍镜视野(HP),并证实为肾小球源性血尿; ② 反复或持续高血压≥3次于不同时间点测量的收缩压和(或)舒张压大于同性别、年龄和身高的儿童青少年血压的第95百分位数,并除外糖皮质激素等原因所致; ③ 肾功能异常,并排除由于血容量不足等所致; ④ 持续低补体血症。 

Exclusion criteria:

1. patients with obvious hormone side effects, intolerance to hormones or hormone contraindications were excluded; 2. nephritic nephrotic syndrome (NNS) was excluded, i.e., one or more of the following four items: (1) Three centrifugal uroscopy examinations of erythrocyte > 10/high power microscopic field of vision (HP) were performed within 2 weeks, respectively, and confirmed to be glomerulogenic hematuria; (2) repeated or sustained hypertension 3 at different time points measured systolic blood pressure and/or diastolic blood pressure is greater than the same gender, age and height of children and adolescents of the 95th percentile of blood pressure, and the exception of glucocorticoid and other reasons; (3) renal dysfunction, and excluded due to insufficient blood volume; (4) persistent low complement blood disease. 

研究实施时间:

Study execute time:

From2019-06-01To 2019-12-31 

干预措施:

Interventions:

组别:

SSNS

样本量:

32

Group:

SSNS

Sample size:

干预措施:

干预措施代码:

Intervention:

Intervention code:

组别:

FRNS/SDNS

样本量:

64

Group:

FRNS/SDNS

Sample size:

干预措施:

干预措施代码:

Intervention:

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):

重庆市辖 

Country:

China 

Province:

Chongqing 

City:

Chongqing 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三甲医院 

Institution
hospital:

Children's Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

基因分型

指标类型:

主要指标 

Outcome:

Genetic variants

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:

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 0.5 years
最大 Max age 18 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):

队列研究,非随机化

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

Cohort study, nonrandomized

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:

即时公开/Real time access

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临床试验公共管理平台

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

Clinical Trial Management Public Platform

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:

采用病例记录表和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:

Case Record Form and Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-05-15
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