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The study of neonatal urinary exosome MXRA5 used as a clinical prognostic marker for congenital hydronephrosis
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注册号:

Registration number:

ChiCTR2000033268 

最近更新日期:

Date of Last Refreshed on:

2020-05-25 

注册时间:

Date of Registration:

2020-05-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

王琪医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 新生儿尿外泌体MXRA5用于先天性肾积水临床转归预测指标的研究 

Public title:

The study of neonatal urinary exosome MXRA5 used as a clinical prognostic marker for congenital hydronephrosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新生儿尿外泌体MXRA5用于先天性肾积水临床转归预测指标的研究 

Scientific title:

The study of neonatal urinary exosome MXRA5 used as a clinical prognostic marker for congenital hydronephrosis 

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:

王琪 

研究负责人:

姜大朋 

Applicant:

Qi Wang 

Study leader:

Dapeng Jiang 

申请注册联系人电话:

Applicant telephone:

+86 13127772545 

研究负责人电话:

Study leader's telephone:

+86 13671785132 

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:

windywq@sjtu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

jdp509@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:

上海市浦东新区东方路1678号 

研究负责人通讯地址:

上海市浦东新区东方路1678号 

Applicant address:

1678 Dongfang Road, Pudong New Area, Shanghai 

Study leader's address:

1678 Dongfang Road, Pudong New Area, Shanghai 

申请注册联系人邮政编码:

Applicant postcode:

200127 

研究负责人邮政编码:

Study leader's postcode:

200127 

申请人所在单位:

上海交通大学医学院附属上海儿童医学中心 

Applicant's institution:

Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

上海交通大学医学院附属上海儿童医学中心 

Primary sponsor:

Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine 

研究实施负责(组长)单位地址:

上海市浦东新区东方路1678号 

Primary sponsor's address:

1678 Dongfang Road, Pudong New Area, Shanghai 

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):

上海交通大学医学院附属上海儿童医学中心

具体地址:

浦东新区东方路1678号

Institution
hospital:

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

Address:

1678 Dongfang Road, Pudong New Area

经费或物资来源:

上海交通大学医学院附属上海儿童医学中心 

Source(s) of funding:

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine 

研究疾病:

先天性肾积水 

Target disease:

Congenital hydronephrosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本项目研究目的在于揭示MXRA5 在UPJO 新生儿尿液exosome 中表达的内在规律;通过以肾积水新生儿人群为基础的前瞻性队列研究,探索MXRA5 与新生儿肾积水临床结局的关联度,从而确定MXRA5 作为灵敏度高和重复性好的UPJO 继发肾损伤的早期诊断标志物,用于预测新生儿肾积水的临床转归并在临床进行推广应用。 

Objectives of Study:

The purpose of this study is to reveal the internal regulation of MXRA5 expression in UPJO newborn urinary exosome. A prospective cohort study based on the neonate population of hydronephrosis is conducted to explore the correlation between MXRA5 and the clinical outcome of neonate hydronephrosis.We hope to determine MXRA5 as an early diagnostic marker of renal injury caused by UPJO with high sensitivity and great repeatability, and can be used to predict the clinical outcome of neonate hydronephrosis in clinical applications  

药物成份或治疗方案详述:

1.提取及鉴定新生儿尿液来源exosome; 2.检测尿MXRA5表达水平及评估其对新生儿肾积水临床转归的预测价值; 3.对MXRA5与超声、同位素检查数据及患肾转归进行关联性分析。 

Description for medicine or protocol of treatment in detail:

1. Extraction and identification of neonatal urinary exosome; 2. The expression level of urine MXRA5 is detected and its predictive value for the clinical outcome of neonatal hydronephrosis is evaluated; 3. Correlation analysis among MXRA5,ultrasonic,isotopic examination data and outcome of disease is conducted. 

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.出生后(单侧病变)肾盂前后径≥10mm 者; 2.经患儿监护人知情同意后,自愿参加本项研究; 3.患儿家长依从性好,能定期复查并接受随访。 

Inclusion criteria

1. Postnatal unilateral renal pelvis anteroposterior diameter(APD)>= 10mm; 2. Voluntarily participate in this study with the informed consent of the guardian of the child; 3. The parents of the child have good compliance, and can regularly check and receive follow-up visits. 

排除标准:

(符合以下任一标准,将不能参加此研究): 1.患内分泌及代谢系统疾病、肝肾疾病、血液系统疾病、遗传性疾病者; 2.患儿接受激素类药物治疗者;双侧肾积水;输尿管膀胱返流者; 3.输尿管扩张或下尿路异常;孤立肾。 

Exclusion criteria:

(Participants who meet any of the following criteria will not be eligible to participate in the study): 1. Patients with diseases of endocrine and metabolic systems, liver and kidney diseases, blood system diseases and genetic diseases; 2. Children receiving hormone drug therapy;Bilateral hydronephrosis;Ureterovesical reflux; 3. Ureteral dilatation or abnormal lower urinary tract;Isolated kidney. 

研究实施时间:

Study execute time:

From2020-07-01To 2023-06-30 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcomes

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

尿外泌体中的基质重塑关联蛋白-5(MXRA5)

Index test:

Matrix remodeling associated protein-5 (MXRA5) in urinary exosomes

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

出生后(单侧病变)肾盂前后径≥10mm 的新生儿。

例数:

Sample size:

411

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

patients with postnatal unilateral renal pelvis anteroposterior diameter(APD)>= 10mm.

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

正常健康新生儿作为对照组

例数:

Sample size:

400

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Normal healthy newborns are used as the control group.

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):

上海交通大学医学院附属上海儿童医学中心 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

exosome内MXRA5 表达

指标类型:

主要指标 

Outcome:

MXRA5 expression in Exosome

Type:

Primary indicator 

测量时间点:

测量方法:

酶联免疫吸附试验

Measure time point of outcome:

Measure method:

ELISA

指标中文名:

尿液上清MXRA5表达

指标类型:

次要指标 

Outcome:

MXRA5 expression in urine supernatant

Type:

Secondary indicator 

测量时间点:

测量方法:

酶联免疫吸附试验

Measure time point of outcome:

Measure method:

ELISA

指标中文名:

肾血流灌注

指标类型:

附加指标 

Outcome:

Renal perfusion

Type:

Additional indicator 

测量时间点:

测量方法:

放射性核素检测

Measure time point of outcome:

Measure method:

Radionuclide test

指标中文名:

肾实质厚度、肾盂前后直径及肾盏形态

指标类型:

附加指标 

Outcome:

Renal parenchymal thickness, anterior and posterior renal pelvis diameter and calyceal morphology

Type:

Additional indicator 

测量时间点:

测量方法:

超声

Measure time point of outcome:

Measure method:

ultrasound

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

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:

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 years
最大 Max age 0.1 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):

本项目为非随机的单中心研究。

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

This is a non-randomized, single-center study.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

2024-01-01将所有原始数据在ResMan公开, http://www.medresman.org.cn。

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

All the electronic version records make public by using ResMan from January 1st, 2024, 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:

Excel和SPSS 26.0

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

Excel and SPSS 26.0

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-05-25
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