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Regulating express of BMP7 through miRNA-542-3p to control EMT for Heterotopic ossification therapy
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注册号:

Registration number:

ChiCTR1800016542 

最近更新日期:

Date of Last Refreshed on:

2018-06-07 

注册时间:

Date of Registration:

2018-06-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

MiRNA-542-3p调控BMP7表达抑制EndMT过程防治异位骨化的机制研究 

Public title:

Regulating express of BMP7 through miRNA-542-3p to control EMT for Heterotopic ossification therapy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

MiRNA-542-3p调控BMP7表达抑制EndMT过程防治异位骨化的机制研究 

Scientific title:

Regulating express of BMP7 through miRNA-542-3p to control EMT for Heterotopic ossification therapy 

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:

仲飙 

研究负责人:

仲飙 

Applicant:

BIAO ZHONG 

Study leader:

BIAO ZHONG 

申请注册联系人电话:

Applicant telephone:

+86 18930177319 

研究负责人电话:

Study leader's telephone:

+86 18930177319 

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:

biao_zhong@163.com 

研究负责人电子邮件:

Study leader's E-mail:

biao_zhong@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:

上海交通大学附属第六人民医院 

Applicant's institution:

Sixth People's Hospital Affiliated to Shanghai Jiao Tong University 

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:

上海交通大学附属第六人民医院 

Primary sponsor:

Sixth People's Hospital Affiliated to Shanghai Jiao Tong University 

研究实施负责(组长)单位地址:

上海市徐汇区宜山路600号 

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):

上海交通大学附属第六人民医院

具体地址:

上海市徐汇区宜山路600号

Institution
hospital:

Sixth People's Hospital Affiliated to Shanghai Jiao Tong University

Address:

600 Yishan Road, Xuhui District, Shanghai

经费或物资来源:

院级课题 

Source(s) of funding:

Hospital level subject  

研究疾病:

异位骨化 

Target disease:

Heterotopic ossification 

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:

本课题拟通过对30对异位骨化的临床样本进行检测,研究BMP7及miRNA-542-3p在异位骨化组织与正常组织中表达水平的差异,同时在异位骨化动物模型组织中进行相关验证。基于miRNA对BMP7蛋白表达的调控,在鼠源细胞和人源细胞中同时验证该调控对EndMT的抑制作用,同时在动物模型上验证miRNA-542-3p的原位注射对异位骨化治疗的效果。通过动物细胞水平和动物体内实验结果,综合异位骨化动物模型和临床样本组织中miRNA和BMP7的表达水平结果,推测miRNA-542-3p在临床上防治异位骨化的可能性及潜在应用价值。 

Objectives of Study:

The purpose of this study is to examine the difference between the expression level of BMP7 and miRNA-542-3p in ectopic ossification and normal tissue by detecting 30 clinical samples of heterotopic ossification, and to verify the correlation in the animal model of ectopic ossification. Based on the regulation of the expression of BMP7 protein by miRNA, the inhibitory effect of this regulation on EndMT was verified in rat and human cells, and the effect of miRNA-542-3p in situ injection on heterotopic ossification was verified in animal models. The possibility and potential application value of miRNA-542-3p in the prevention and treatment of heterotopic ossification were estimated by combining the results of animal cell level and animal experiment, and the results of the expression level of miRNA and BMP7 in the ectopic ossification animal model and clinical sample tissue. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

随机选取我院异位骨化手术治疗患者,依据有异位骨化组织标本及正常肌肉组织标本进行分组,分为异位骨化组和正常组织对照组。 

Inclusion criteria

Randomly selected patients with ectopic ossification in our hospital were divided into heterotopic ossification group and normal tissue control group according to the specimens of heterotopic ossification and normal muscle tissue specimens.  

排除标准:

①合并糖尿病、甲状腺功能亢进、甲状旁腺功能亢进等影响骨代谢的内分泌疾病者; ②合并肝肾功能异常、胃炎、肠炎、类风湿性关节炎或骨肿瘤等恶性肿瘤者。 ③曾行放疗治疗异位骨化者及使用过激素或其他影响骨代谢的药物者; ④一年内发生骨折等导致肢体运动功能受限者。 

Exclusion criteria:

(1) combined with diabetes, hyperthyroidism, hyperparathyroidism, and other endocrine diseases that affect bone metabolism; (2) combined with liver and kidney dysfunction, gastritis, enteritis, rheumatoid arthritis or bone tumors and other malignant tumors; (3) those who had undergone radiotherapy for heterotopic ossification and those who had used hormones or other drugs that affect bone metabolism; (4) fractures within a year may result in limited motor function.  

研究实施时间:

Study execute time:

From2018-07-01To 2018-12-31 

干预措施:

Interventions:

组别:

2

样本量:

30

Group:

2

Sample size:

干预措施:

干预措施代码:

Intervention:

non

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):

上海交通大学附属第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Sixth People's Hospital Affiliated to Shanghai Jiao Tong University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

miRNA

指标类型:

主要指标 

Outcome:

miRNA

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:

异位骨化病灶

组织:

骨质

Sample Name:

Heterotopic ossification

Tissue:

bone

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:

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):

信封法

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

Envelope method

盲法:

Blinding:

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):

百度云 http://pan.baidu.com/

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

baidu http://pan.baidu.com/

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:

病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-06-07
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