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帕金森病核素显像及其他生物学标志物在临床诊断和治疗的研究
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注册号:

Registration number:

ChiCTR-DOC-16008645 

最近更新日期:

Date of Last Refreshed on:

2016-06-15 

注册时间:

Date of Registration:

2016-06-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

帕金森病核素显像及其他生物学标志物在临床诊断和治疗的研究 

Public title:

The study of radionuclide imaging and biomarkers in clinical diagnosis and treatment of Parkinson's disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

帕金森病核素显像及其他生物学标志物在临床诊断和治疗的研究 

Scientific title:

The study of radionuclide imaging and biomarkers in clinical diagnosis and treatment of Parkinson's disease 

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:

林伟 

研究负责人:

林伟 

Applicant:

Lin Wei 

Study leader:

Lin Wei 

申请注册联系人电话:

Applicant telephone:

+86 13812512187 

研究负责人电话:

Study leader's telephone:

+86 13812512187 

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:

smithlinwx@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

smithlinwx@aliyun.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:

江苏省无锡市兴源北路101号 

研究负责人通讯地址:

江苏省无锡市兴源北路101号 

Applicant address:

101 North Xingyuan Road, Wuxi, Jiangsu, China 

Study leader's address:

101 North Xingyuan Road, Wuxi, Jiangsu, 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:

江苏省无锡市解放军101医院 

Applicant's institution:

101th Hospital of PLA 

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:

L2016005 

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:

解放军101医院伦理委员会 

Name of the ethic committee:

Ethics Committee of 101th Hospital of PLA 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-01-02 

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:

解放军101医院 

Primary sponsor:

101th Hospital of PLA  

研究实施负责(组长)单位地址:

江苏省无锡市兴源北路101号 

Primary sponsor's address:

101 North Xinyuan Road, Wuxi, Jiangsu, 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):

江苏省

市(区县):

无锡

Country:

China

Province:

Jiangsu

City:

Wuxi City

单位(医院):

解放军101医院

具体地址:

江苏省无锡市兴源北路101号

Institution
hospital:

101th Hospital of PLA

Address:

101 North Xinyuan Road, Wuxi, Jiangsu, China

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

帕金森病 

Target disease:

Parkinson Disease 

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:

其它 

Study phase:

N/A 

研究目的:

研究目标:1 通过核素显像准确的对于帕金森病患者进行诊断,并尽可能成为早期诊断的有力工具,提早并确立早期PD疾病干预时间窗;2 探索出现运动并发症患者的显像特征,并对可能出现运动并发症的PD患者进行早期预判断,为早期选择合适治疗方案避免或延缓出现运动并发症打下基础。 

Objectives of Study:

1. to dignosis the potential PD patients by radionuclide imaging as early as possible; 2. to explore the imaging characteristics of motor complications of patients and motor complications in PD 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:

单臂 

Study design:

Single arm 

纳入标准:

帕金森病早起患者,帕金森病运动并发症患者; 

Inclusion criteria

early stage PD, motor-complictions PD 

排除标准:

继发性帕金森病患者 

Exclusion criteria:

secondery PD 

研究实施时间:

Study execute time:

From2016-07-01To 2018-06-30 

征募观察对象时间:

Recruiting time:

From2016-07-01To 2017-06-30 

诊断试验:

Diagnostic Tests:

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):

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):

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):

Index test:

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)

例数:

Sample size:

0

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):

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:

测量指标:

Outcomes:

指标中文名:

纹状体/小脑比

指标类型:

主要指标 

Outcome:

striatal-to-occipital ratio, SOR

Type:

Primary indicator 

测量时间点:

测量方法:

核素显像, 以3层ROI的平均计数计算

Measure time point of outcome:

Measure method:

Radionuclide imaging

指标中文名:

PDRP值

指标类型:

主要指标 

Outcome:

PDRP value

Type:

Primary indicator 

测量时间点:

测量方法:

获取尾状核和壳核的摄取指数,可半定量反映这些部位DAT的数量和功能,并通过FDG代谢现象计算PDRP值

Measure time point of outcome:

Measure method:

The caudate and putamen uptake index for calculate the DAT, and FDG

指标中文名:

帕金森综合评分量表

指标类型:

次要指标 

Outcome:

UPDRSIII

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知功能、视空间能力、非词语记忆力、注意力、执行功能测试

指标类型:

次要指标 

Outcome:

Cognitive function, visual spatial ability, non verbal memory, attention, executive function test

Type:

Secondary indicator 

测量时间点:

测量方法:

MMSE, MoCA instruments

Measure time point of outcome:

Measure method:

MMSE, MoCA instruments

采集人体标本:

Collecting sample(s)
from participants:

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 18 years
最大 Max age 80 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):

非随机研究

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

non-randomized studies

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

2020-01-01,在线

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

2020-01-01,online

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:

用本院开发帕金森数据库

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

Using databas developed by out institute

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-06-15
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