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双胎妊娠队列研究:探究生命早期基因-环境复杂的交互作用,及其在婴幼儿相关疾病早期预 测中的作用
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注册号:

Registration number:

ChiCTR-OOC-16008203 

最近更新日期:

Date of Last Refreshed on:

2016-04-01 

注册时间:

Date of Registration:

2016-04-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

双胎妊娠队列研究:探究生命早期基因-环境复杂的交互作用,及其在婴幼儿相关疾病早期预 测中的作用 

Public title:

Unraveling the complex interplay between genes and environment in specifying early life determinants of illness in infancy: a longitudinal prenatal study of Chinese Twins 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

双胎妊娠队列研究:探究生命早期基因-环境复杂的交互作用,及其在婴幼儿相关疾病早期预 测中的作用 

Scientific title:

Unraveling the complex interplay between genes and environment in specifying early life determinants of illness in infancy: a longitudinal prenatal study of Chinese Twins 

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:

漆洪波 

研究负责人:

漆洪波 

Applicant:

Hongbo Qi 

Study leader:

Hongbo Qi 

申请注册联系人电话:

Applicant telephone:

+86 13618399556 

研究负责人电话:

Study leader's telephone:

+86 13618399556 

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:

to10@163.com 

研究负责人电子邮件:

Study leader's E-mail:

to10@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:

重庆市渝中区友谊路1号 

研究负责人通讯地址:

重庆市渝中区友谊路1号 

Applicant address:

1 Youyi Road, Yuzhong District, Chongqing, China 

Study leader's address:

1 Youyi Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Chongqing Medical 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:

201530 

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:

重庆医科大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethic Committee of The First Affiliated Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-02-29 

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:

重庆医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区友谊路1号 

Primary sponsor's address:

1 Youyi Road, Yuzhong District, Chongqing, 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):

重庆市

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属第一医院

具体地址:

重庆市渝中区友谊路1号

Institution
hospital:

The First Affiliated Hospital of Chongqing Medical University

Address:

1 Youyi Road, Yuzhong District, Chongqing, China

经费或物资来源:

国家自然科学基金重点国际合作研究项目 

Source(s) of funding:

National Natural Science Foundation of China  

研究疾病:

双胎妊娠 

Target disease:

Twin pregnancy 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本项目重点提出一种创新性的研究模式—基于纵向前瞻性双胎队列的人类胎源性婴幼儿相关疾病的起源机制研究。 总体研究目标旨在探讨导致婴幼儿非遗传疾病发生的潜在可调节环境因素,以及关键的干预时间点,从而为起源于生命早期的婴幼儿相关疾病提供新的预防及治疗策略。 

Objectives of Study:

Our proposal is an innovative approach towards investigating the mechanisms underlying the development of illness in infancy. The establishment of a dedicated twin birth cohort in Chongqing, recruited during pregnancy, will enable an unparalleled investigation of the link between genetic risk, early life environment, mediating mechanisms, and early life phenotypes and disorders (such as allergic conditions), including predictive biomarkers present in childhood associated with later development of neurodevelopmental, cardiovascular and/or metabolic dysfunction. Non-invasive risk phenotypes, reproducibly and readily quantified in children often track from mid-childhood into adulthood, and therefore act as intermediate phenotypes toward adult disease. Our proposal builds on previous learning from the Australian PETS cohort (Melbourne, Australia) to enable the establishment of a dedicated Chinese prenatal/antenatal twin cohort for investigating the early life determinants of illnesses in infancy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

在重庆医科大学附属第一医院接受产前检查,经超声检查并确认为双胎妊娠7-14周的妇女,将被邀请参与本项研究。 

Inclusion criteria

All women pregnant with twins will be invited to participate in this study once identified in The First Affiliated Hospital of Chongqing Medical University, department of obstetrics. Dedicated research midwives will constantly monitor women attending clinics and identify those newly detected by ultrasound as carrying twins, before 14 weeks gestation.  

排除标准:

双胎输血综合征,双胎贫血-红细胞增多序列征,双胎动脉反向灌注综合征,双胎之一死亡,双胎之一畸形 

Exclusion criteria:

Twin twin transfusion syndrome (TTTS), twin anemia - polycythemia sequence (TAPS), Twins reversed arterial perfusion sequence(TRAPS), Deaths of one of twins, Malformation of one of twins. 

研究实施时间:

Study execute time:

From2016-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

双胎孕妇

样本量:

300

Group:

twin-pregnant women

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市妇幼保健院 

单位级别:

三甲 

Institution
hospital:

Chongqing Health Center For Women and Children  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三甲 

Institution
hospital:

Children‘s Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

第三军医大学附属大坪医院 

单位级别:

三甲 

Institution
hospital:

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

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

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

头发

组织:

Sample Name:

hair

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

指甲

组织:

Sample Name:

Nail

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

颊粘膜拭子

组织:

Sample Name:

Buccal swab

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 40 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

N/A

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

N/A

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):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

在临床试验公共平台ResMan共享

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

Sharing the individual participant data via ResMan

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:

ResMan

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

ResMan

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-04-01
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