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面肩肱型肌营养不良症的登记研究
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注册号:

Registration number:

ChiCTR2000031016 

最近更新日期:

Date of Last Refreshed on:

2020-03-21 

注册时间:

Date of Registration:

2020-03-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

面肩肱型肌营养不良症的登记研究 

Public title:

A Registration Study of Facioscapulohumeral Muscular Dystrophy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

面肩肱型肌营养不良症的登记研究 

Scientific title:

A Registration Study of Facioscapulohumeral Muscular Dystrophy 

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:

林琳 

研究负责人:

王志强 

Applicant:

Lin Lin 

Study leader:

Zhiqiang Wang 

申请注册联系人电话:

Applicant telephone:

+86 15060830010 

研究负责人电话:

Study leader's telephone:

+86 13615039279 

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:

527606186@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

fmuwzq@fjmu.edu.cn 

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:

福建省福州市台江区茶中路20号 

研究负责人通讯地址:

福建省福州市台江区茶中路20号 

Applicant address:

20 Chazhong Road, Taijiang District, Fuzhou, Fujian, China 

Study leader's address:

20 Chazhong Road, Taijiang District, Fuzhou, Fujian, China 

申请注册联系人邮政编码:

Applicant postcode:

350005 

研究负责人邮政编码:

Study leader's postcode:

350005 

申请人所在单位:

福建医科大学附属第一医院 

Applicant's institution:

First Affiliated Hospital of Fujian 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:

闽医大附一伦理医研[2020]026号 

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:

福建医科大学附属第一医院医学伦理委员会医学研究与临床技术应用分会 

Name of the ethic committee:

Branch for Medical Research and Clinical Technology Application, Ethics Committee of the First Affiliated Hospital of Fujian Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

王柠 

Contact Name of the ethic committee:

Ning Wang 

伦理委员会联系地址:

福建省福州市台江区茶中路20号 

Contact Address of the ethic committee:

20 Chazhong Road, Taijiang District, Fuzhou, Fujian, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 591-87981028 

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:

福建医科大学附属第一医院 

Primary sponsor:

First Affiliated Hospital of Fujian Medical University 

研究实施负责(组长)单位地址:

福建省福州市台江区茶中路20号 

Primary sponsor's address:

20 Chazhong Road, Taijiang District, Fuzhou, Fujian, 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):

福建省

市(区县):

福州市

Country:

China

Province:

Fujian

City:

Fuzhou

单位(医院):

福建医科大学附属第一医院

具体地址:

福建省福州市台江区茶中路20号

Institution
hospital:

First Affiliated Hospital of Fujian Medical University

Address:

20 Chazhong Road, Taijiang 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:

面肩肱型肌营养不良症 

Target disease:

Facioscapulohumeral Muscular Dystrophy 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

建立面肩肱型肌营养不良症患者、携带者及其家系成员登记队列,研究其遗传及表观遗传规律,分析发病因素。 

Objectives of Study:

To establish a registration cohort of patients, carriers and their family members with facioscapulohumeral muscular dystrophy, to study their genetic and epigenetic laws and to analyze the pathogenic factors. 

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.已确诊1型或2型面肩肱型肌营养不良症患者与携带者及其家系成员。 2.患者本人或其法定监护人自愿患者参加,并签署知情同意书。 

Inclusion criteria

1. Patients and carriers diagnosed with type 1 or type 2 facioscapulohumeral muscular dystrophy and their family members; 2. The patient himself or his legal guardian voluntarily participated in the event and signed the informed consent. 

排除标准:

1.严重合并症。 2.不能配合检查及随访者。 

Exclusion criteria:

1. Patients with severe complications; 2. Patients who cannot cooperate with the examination and follow-up. 

研究实施时间:

Study execute time:

From2020-04-01To 2030-07-01 

干预措施:

Interventions:

组别:

Case series

样本量:

5000

Group:

Case series

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建省 

市(区县):

福州市 

Country:

China 

Province:

Fujian 

City:

Fuzhou 

单位(医院):

福建医科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

First Affiliated Hospital of Fujian Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

临床严重程度评分

指标类型:

主要指标 

Outcome:

CCS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手动肌力测评

指标类型:

主要指标 

Outcome:

MMT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌肉磁共振

指标类型:

次要指标 

Outcome:

Muscular MRI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌肉损伤指标

指标类型:

次要指标 

Outcome:

Index of muscle injury

Type:

Secondary 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 0 years
最大 Max age 100 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):

N/A

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

N/A

盲法:

Blinding:

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):

医渡云科研协作平台(https://research.yiducloud.com.cn)

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

Yiducloud Research Collaboration Platform(https://research.yiducloud.com.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:

CRF表采集数据;医渡云科研协作平台管理数据

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

CRF;Yiducloud Research Collaboration Platform

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-21
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