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Construction of cohort and prognosis prediction model of multiple system atrophy
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注册号:

Registration number:

ChiCTR2000033282 

最近更新日期:

Date of Last Refreshed on:

2020-05-31 

注册时间:

Date of Registration:

2020-05-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

多系统萎缩队列及预后预测模型的构建 

Public title:

Construction of cohort and prognosis prediction model of multiple system atrophy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

多系统萎缩队列及预后预测模型的构建 

Scientific title:

Construction of cohort and prognosis prediction model of multiple system atrophy 

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:

魏倩倩 

研究负责人:

商慧芳 

Applicant:

Qianqian Wei 

Study leader:

Huifang Shang 

申请注册联系人电话:

Applicant telephone:

+86 15982161308 

研究负责人电话:

Study leader's telephone:

+86 18980602127 

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:

578361552@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

hfshang2002@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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital of Sichuan 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:

2019922 

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:

四川大学华西医院生物医学伦理专委会 

Name of the ethic committee:

Biomedical Ethical Committee of West China Hospital of Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-24 

伦理委员会联系人:

李娜 

Contact Name of the ethic committee:

Na Li 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号 

Contact Address of the ethic committee:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital of Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

武侯区国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

37 Guoxue Lane, Wuhou District

经费或物资来源:

四川大学华西医院学科卓越发展1·3·5工程临床研究孵化项目 

Source(s) of funding:

1·3·5 project for disciplines of excellence–Clinical Research Incubation Project, West China Hospital, Sichuan University 

研究疾病:

多系统萎缩 

Target disease:

Multiple system atrophy 

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:

1)筛选具有预后预测价值的临床、遗传学、神经影像学和生物学指标; 2)从多维度构建多个MSA临床结局(认知障碍、卧床和死亡)的个体化预后预测模型。 

Objectives of Study:

1.Screen clinical, genetic, neuroimaging and biological indicators with prognostic value; 2.Construct individualized prognostic prediction model for clinical outcomes (cognitive impairment, bed rest, and death) in MSA. 

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2008年Gilman等提出的第二版诊断标准中达到很可能的MSA(probable MSA)诊断的患者; (3)能够完成临床评估、静脉采血、腰椎穿刺检查; (2)自愿参加研究,签署知情同意书; (4)基线时不出现认知障碍和卧床。 

Inclusion criteria

1. The patients who met the most likely MSA (probable MSA) diagnosis in the second edition of the diagnostic standard proposed by Gilman et al; 2. Patients who voluntarily participated in the study and signed the informed consent; 3. Patients who can complete clinical evaluation, venous blood collection and lumbar puncture; 4. Patients without cognitive impairment or bed rest at baseline. 

排除标准:

(1)合并脑血管病史、严重头部外伤史及其他神经精神病史; (2)拒绝随访; (3)发病年龄大于75岁; (4)共济失调或帕金森综合征家族史。 

Exclusion criteria:

1. Patients with cerebrovascular history, severe head injury history and other neuropsychological history; 2. Patients who refuse to follow up; 3. Patients over 75 years old; 4. With family history of ataxia or Parkinson's syndrome. 

研究实施时间:

Study execute time:

From2019-12-01To 2024-11-30 

征募观察对象时间:

Recruiting time:

From2020-06-01To 2024-11-29 

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):

多系统萎缩预后预测模型

Index test:

Prognosis prediction model of multiple system atrophy

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)

符合2008年Gilman等提出的第二版诊断标准中达到很可能的MSA(probable MSA)诊断的患者。

例数:

Sample size:

600

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):

The patients who met the most likely MSA (probable MSA) diagnosis in the second edition of the diagnostic standard.

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):

例数:

Sample size:

0

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

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

疾病的严重程度

指标类型:

主要指标 

Outcome:

The severity of the disease

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

实验室检查

指标类型:

主要指标 

Outcome:

Laboratory inspection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人口学

指标类型:

主要指标 

Outcome:

Demography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病史

指标类型:

主要指标 

Outcome:

Medical history

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

非运动症状

指标类型:

主要指标 

Outcome:

Non-motor symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经电生理指标

指标类型:

主要指标 

Outcome:

Neuroelectrophysiological indicators

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影像学检查

指标类型:

主要指标 

Outcome:

Imaging inspection

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:

标本中文名:

脑脊液

组织:

Sample Name:

Cerebrospinal fluid

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

Feces

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

皮肤

组织:

Sample Name:

Skin

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

唾液

组织:

Sample Name:

Saliva

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 30 years
最大 Max age 75 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):

不适用

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

N/A

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):

ResMan临床试验公共管理平台, 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:

四川大学华西医院

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

West China Hospital of Sichuan University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-05-26
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