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血清IL-6:结缔组织病相关肺动脉高压的新型预测因子
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注册号:

Registration number:

ChiCTR1900028152 

最近更新日期:

Date of Last Refreshed on:

2019-12-13 

注册时间:

Date of Registration:

2019-12-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

血清IL-6:结缔组织病相关肺动脉高压的新型预测因子 

Public title:

Serum interleukins-6: a predictive biomarker for connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

血清IL-6:结缔组织病相关肺动脉高压的新型预测因子 

Scientific title:

Serum interleukins-6: a predictive biomarker for connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) 

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:

秦雨晗 

研究负责人:

汤成春 

Applicant:

Yuhan Qin 

Study leader:

Chengchun Tang 

申请注册联系人电话:

Applicant telephone:

+86 15851869029 

研究负责人电话:

Study leader's telephone:

+86 13914705570 

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:

986742402@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

tangchengchun@hotmail.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:

南京市鼓楼区丁家桥87号 

研究负责人通讯地址:

南京市鼓楼区丁家桥87号 

Applicant address:

87 Ding-Jia-Qiao, Gulou District, Nanjing, Jiangsu, China 

Study leader's address:

87 Ding-Jia-Qiao, Gulou District, Nanjing, 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:

东南大学医学院 

Applicant's institution:

Medical School, Southeast 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:

中大医院 

Primary sponsor:

Zhongda Hospital Affiliated to Southeast University 

研究实施负责(组长)单位地址:

南京市鼓楼区丁家桥87号 

Primary sponsor's address:

87 Ding-Jia-Qiao, Gulou District, Nanjing, 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

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

东南大学附属中大医院

具体地址:

南京市鼓楼区丁家桥87号

Institution
hospital:

Zhongda Hospital Affiliated to Southeast University

Address:

87 Ding-Jia-Qiao, Gulou District, Nanjing

经费或物资来源:

自理 

Source(s) of funding:

own expense 

研究疾病:

肺动脉高压 

Target disease:

pulmonary arterial hypertension 

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:

研究外周血血清IL-6在结缔组织病相关肺动脉高压患者中的预测价值 

Objectives of Study:

explore the predictive value of serum IL-6 on CTD-PAH 

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:

接受右心导管检查明确诊断为结缔组织病相关肺动脉高压患者 

Inclusion criteria

participants received right heart catheterization examination and were clearly diagnosed as PAH.  

排除标准:

遗传性PAH,药物等诱导的PAH,特发性PAH或与慢性阻塞性肺疾病(COPD),阻塞性睡眠呼吸暂停低通气综合征(OSAHS),慢性血栓栓塞相关的肺动脉高压(CTEPH),左心疾病相关的PH及间质性肺疾病患者被排除。 

Exclusion criteria:

Patients were excluded if they have heritable PAH, drugs/toxins induced PAH, idiopathic PAH or PH associated with chronic obstructive pulmonary disease (COPD), obstructive sleep apnea-hypopnea syndrome(OSAHS), chronic thromboembolic pulmonary hypertension (CTEPH), left heart disease, interstitial lung disease.  

研究实施时间:

Study execute time:

From2020-01-01To  

征募观察对象时间:

Recruiting time:

From2020-01-01To 2022-12-31 

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):

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 outcome

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):

外周血血清IL-6

Index test:

serum IL-6

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)

结缔组织病相关肺动脉高压患者

例数:

Sample size:

200

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 connective tissue disease-associated pulmonary arterial hypertension

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):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

东南大学附属中大医院 

单位级别:

三甲医院 

Institution
hospital:

Zhongda hospital affiliated to southeast university  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

IL-6

指标类型:

主要指标 

Outcome:

CTD-PAH

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

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):

无需随机

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

No

盲法:

未说明

Blinding:

Not stated

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

是Yes

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):

采用网络平台

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

Use web-bassed public database

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:

数据采集由研究者完成,采取纸质版(CRF)和电子化数据保存和管理,电子采集和管理系统由东南大学医学院统计学教研室提供

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

The case records were collected by researchers by paper version (CRF) and electronic data storage and management,and the electronic collection and management system was provided by the statistics department of medical school of Southeast university

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-13
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