Today is 2022-07-07

Proteomic screening and analysis of plasma secrete protein markers in patients with post-stroke depression
download

注册号:

Registration number:

ChiCTR2200060072 

最近更新日期:

Date of Last Refreshed on:

2022-05-17 

注册时间:

Date of Registration:

2022-05-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

PSD患者血浆外泌体蛋白标志物的蛋白质组学筛选与分析 

Public title:

Proteomic screening and analysis of plasma secrete protein markers in patients with post-stroke depression 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

精神神经学科 

Scientific title:

Psychoneurology 

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:

张红丽 

研究负责人:

岳学静 

Applicant:

Hongli Zhang 

Study leader:

Xuejing Yue 

申请注册联系人电话:

Applicant telephone:

+8615663181871 

研究负责人电话:

Study leader's telephone:

+8613938736494 

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:

550192688@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

jing04001825@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:

河南省新乡市金穗大道601号 

研究负责人通讯地址:

河南省新乡市金穗大道601号 

Applicant address:

601, Jinsui Avenue, Xinxiang City, Henan Province 

Study leader's address:

601, Jinsui Avenue, Xinxiang City, Henan Province 

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:

新乡医学院 

Applicant's institution:

Xinxiang Medical 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:

新乡医学院 

Primary sponsor:

Xinxiang Medical University 

研究实施负责(组长)单位地址:

河南省新乡市金穗大道601号 

Primary sponsor's address:

601, Jinsui Avenue, Xinxiang City, Henan Province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河南

市(区县):

新乡

Country:

China

Province:

Henan

City:

Xinxiang

单位(医院):

新乡医学院第二附属医院

具体地址:

河南省新乡市牧野区前进路207号

Institution
hospital:

The Second Affiliated Hospital of Xinxiang Medical University

Address:

207 Qianjin Road, Muye District, Xinxiang City, Henan Province

经费或物资来源:

新乡医学院第二附属医院 

Source(s) of funding:

The Second Affiliated Hospital of Xinxiang Medical University 

研究疾病:

卒中后抑郁 

Target disease:

post-stroke depression 

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:

探索卒中后抑郁症患者的早期诊断及药物疗效监测等密切相关的生物学标志物,以探讨外泌体是否通过调控神经细胞分泌表达的蛋白质影响抑郁症的病程 

Objectives of Study:

To explore closely related biomarkers such as early diagnosis and drug efficacy monitoring in patients with post-stroke depression, so as to explore whether exosomes affect the course of depression by regulating the proteins secreted and expressed by nerve cells 

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:

1.符合临床诊断被确诊为卒中后抑郁的患者; 2.具有完整临床数据的患者; 3.同意配合和协助我院医务人员完成调查及签署知情同意书的患者 

Inclusion criteria

1.Patients diagnosed with post-stroke depression according to clinical diagnosis; 2.Patients with complete clinical data; 3.Patients who agree to cooperate with and assist the medical staff of our hospital to complete the investigation and sign the informed consent form. 

排除标准:

1.患有恶性肿瘤或严重器官功能障碍的患者; 2.患有传染病的患者; 3.治疗依从性差的患者; 4.身体残疾的患者; 5.中途退出实验的患者 

Exclusion criteria:

1. Patients with malignant tumors or severe organ dysfunction; 2. Patients with infectious diseases; 3. Patients with poor treatment compliance; 4. Patients with physical disabilities; 5. Patients who withdraw from the experiment 

研究实施时间:

Study execute time:

From2022-09-01To 2024-08-01 

征募观察对象时间:

Recruiting time:

From2022-09-01To 2023-02-01 

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):

脑卒中、卒中后抑郁、抑郁症诊断标准

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):

Diagnostic criteria of stroke, post-stroke depression and depression

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):

外泌体

Index test:

exosome

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)

卒中后抑郁患者

例数:

Sample size:

60

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 post-stroke depression

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):

抑郁症患者

例数:

Sample size:

60

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):

河南 

市(区县):

新乡 

Country:

China 

Province:

Henan 

City:

Xinxiang 

单位(医院):

新乡医学院第二附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

The Second Affiliated Hospital of Xinxiang Medical University  

Level of the institution:

Third-class hospital 

测量指标:

Outcomes:

指标中文名:

外泌体蛋白

指标类型:

主要指标 

Outcome:

exosome

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:

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):

患者按照实际情况由临床医生进行分组

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

Patients are grouped by clinicians according to the actual situation

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

不共享原始数据

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

No IPD sharing

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:

通过病历记录表采取患者数据

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

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-05-17
return list