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鲜红斑痣及其综合征发病机制的研究
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注册号:

Registration number:

ChiCTR1900022401 

最近更新日期:

Date of Last Refreshed on:

2019-04-10 

注册时间:

Date of Registration:

2019-04-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

鲜红斑痣及其综合征发病机制的研究 

Public title:

Pathogenesis of port wine stains and port wine stains associated syndromes 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

鲜红斑痣及其综合征发病机制及全基因组测序的研究 

Scientific title:

Port wine stains and port wine stains associated syndrome: A study of pathogenesis and whole genome sequencing  

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:

刘莲 

研究负责人:

蒋献 

Applicant:

Liu Lian 

Study leader:

Jiang Xian 

申请注册联系人电话:

Applicant telephone:

+86 028-85423319 

研究负责人电话:

Study leader's telephone:

+86 028-85423319 

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:

754488032@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

jennyxianj@163.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:

610041 

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, 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:

2018-563 

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分委会 

Name of the ethic committee:

Biomedical Ethics Committee of West China Hospital, Sichuan university 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-11 

伦理委员会联系人:

孙荣国 

Contact Name of the ethic committee:

Sun Rongguo 

伦理委员会联系地址:

四川省成都市武侯区国学巷38号四川大学华西临床医院伦理办公室  

Contact Address of the ethic committee:

Room 412, Old 8th Teaching Building, West China Hospital, Sichuan University, 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, 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:

Chendu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

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

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

研究疾病:

鲜红斑痣及其综合征 

Target disease:

Port wine stains and port wine stains associated syndrome 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

探讨鲜红斑痣及其综合征的可能发病机制及致病基因,增强对其的临床认识,并为治疗提供可能的理论依据。 

Objectives of Study:

To explore the possible pathogenesis and pathogenic genes of port wine stains and its syndrome, to enhance the clinical understanding and provide theoretical basis for treatment 

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

经临床确诊的鲜红斑痣或(和)综合征(SWS、KTS、PKWS、PPV等)的患者; 因诊断或治疗需要,需留取血液标本和(或)皮肤病理组织标本的患者; 自愿捐赠生物样本的患者; 年龄不限; 受试者或监护人签署书面知情同意书者。 

Inclusion criteria

1. Patients with clinically confirmed port wine stains or (and) syndrome (SWS, KTS, PKWS, PPV, etc.); 2. Patients who require blood specimens and/or skin pathology specimens for diagnostic or therapeutic needs; 3. Any age patients who voluntarily donate biological samples; 4. The subject or guardian signs a written informed consent form. 

排除标准:

妊娠妇女; 患有遗传性或获得性凝血障碍者或正在使用抗凝血药物者; 患有严重的神经、精神疾病者。 

Exclusion criteria:

1. Pregnancy; 2. People with hereditary or acquired coagulopathy or who are taking anticoagulant drugs; 3. People with severe neurological and mental diseases. 

研究实施时间:

Study execute time:

From2019-04-15To 2024-04-09 

干预措施:

Interventions:

组别:

Case series

样本量:

250

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

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, SiChuan University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

突变基因

指标类型:

主要指标 

Outcome:

mutation gene

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

组织病理特征

指标类型:

主要指标 

Outcome:

Histopathological manifestations

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮肤镜特征

指标类型:

主要指标 

Outcome:

dermatoscopic manifestations

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:

静脉血

组织:

皮肤组织

Sample Name:

Venous blood

Tissue:

Skin 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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 1 years
最大 Max age 70 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):

符合纳入标准的患者均作为观察对象,不随机分组

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

Patients who met the criteria were treated as observing objects, not randomly grouped

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):

预计在试验完成后6月内公开数据,通过论文形式发表

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

Data is expected to be published in the form of paper within 6 months after the research

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:

照片记录、病例记录以及各类检测报告都将以纸本及电子形式同时储存于四川大学华西医院。

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

All collected results will be stored with paper and digital formats in West China Hospital, SiChuan University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-10
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