膳食因素协同基因风险对泌尿系结石发病的交互作用研究

注册号:

Registration number:

ChiCTR1900028397 

最近更新日期:

Date of Last Refreshed on:

2019-12-20 21:10:42 

注册时间:

Date of Registration:

2019-12-20 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

膳食因素协同基因风险对泌尿系结石发病的交互作用研究

Public title:

Research for the interactive effects between dietary and SNP on urolithiasis within upper urinary tract

注册题目简写:

English Acronym:

研究课题的正式科学名称:

膳食因素协同基因风险对泌尿系结石发病的交互作用研究

Scientific title:

Research for the interactive effects between dietary and SNP on urolithiasis within upper urinary tract

研究课题代号(代码):

Study subject ID:

中国医科大学附属盛京医院科研项目 (MC05)

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:

白松 

研究负责人:

白松 

Applicant:

Song Bai 

Study leader:

Song Bai 

申请注册联系人电话:

Applicant telephone:

+86 18940255568

研究负责人电话:

Study leader's
telephone:

+86 18940255568

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:

baisongcmu@163.com

研究负责人电子邮件:

Study leader's E-mail:

baisongcmu@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:

中国辽宁沈阳市和平区三好街36号

研究负责人通讯地址:

中国辽宁沈阳市和平区三好街36号

Applicant address:

36 Sanhao Street, Shenyang, Liaoning, China

Study leader's address:

36 Sanhao Street, Shenyang, Liaoning, China

申请注册联系人邮政编码:

Applicant postcode:

110004

研究负责人邮政编码:

Study leader's postcode:

110004

申请人所在单位:

中国医科大学附属盛京医院 泌尿外科

Applicant's institution:

Department of Urology, ShengJing Hospital of China Medical University

研究负责人所在单位:

中国医科大学附属盛京医院 泌尿外科

Affiliation of the Leader:

Department of Urology, ShengJing Hospital of China Medical University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2019PS679K

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:

中国医科大学附属盛京医院伦理委员会批准

Name of the ethic committee:

ethics committee of Shengjing Hospital of China Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-06 00:00:00

伦理委员会联系人:

赵玉虹

Contact Name of the ethic committee:

Yuhong Zhao

伦理委员会联系地址:

中国医科大学附属盛京医院 伦理委员会 沈阳市和平区三好街36号,邮编110004

Contact Address of the ethic committee:

Department of ethics committee, ShengJing Hospital of China Medical University, 36 Sanhao Street, Shenyang, Liaoning, 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:

中国医科大学附属盛京医院 泌尿外科

Primary sponsor:

Department of Urology, ShengJing Hospital of China Medical University

研究实施负责(组长)单位地址:

中国辽宁沈阳市和平区三好街36号

Primary sponsor's address:

36 Sanhao Street, Shenyang, Liaoning, 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):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

中国医科大学附属盛京医院

具体地址:

中国医科大学附属盛京医院 泌尿外科 沈阳市和平区三好街36号,邮编110004

Institution
hospital:

Shengjing Hospital of China Medical University

Address:

36 Sanhao Street, Shenyang, Liaoning, China

经费或物资来源:

中国医科大学附属盛京医院科研项目 (MC05)

Source(s) of funding:

Shengjing Hospital Science and Technology Program (MC05)

研究疾病:

泌尿系结石  

Target disease:

urolithiasis

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

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

研究目的:

本研究的目的是研究总结人群膳食模式对泌尿系结石发病风险的调控作用,以及不同泌尿系结石基因风险人群的膳食模式与泌尿系结石基因风险对泌尿系结石发病的单独作用和交互作用。  

Objectives of Study:

We aim to discover the association between urolithiasis and dietary patterns, and to explore the independent and interactive effects between dietary patterns and SNP on urolithiasis within upper urinary tract.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

排除无法获得膳食信息或临床信息的患者。

Exclusion criteria:

Patients with unavailable dietary or clinical information were excluded.

研究实施时间:

Study execute time:

From 2019-12-27 00:00:00 To 2020-04-27 00:00:00  

征募观察对象时间:

Recruiting time:

From 2019-12-27 00:00:00 To 2020-03-27 00:00:00

干预措施:

Interventions:

组别:

对照组

样本量:

200

Group:

Group 2

Sample size:

干预措施:

健康人群

干预措施代码:

Intervention:

Health population

Intervention code:

组别:

实验组

样本量:

200

Group:

Group 1

Sample size:

干预措施:

罹患上尿路结石

干预措施代码:

Intervention:

Upper urinary calculus patients

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

中国医科大学附属盛京医院 

单位级别:

三甲 

Institution
hospital:

Department of Urology, ShengJing Hospital of China Medical University

Level of the institution:

Tertiary A Hospital

测量指标:

Outcomes:

指标中文名:

饮食史

指标类型:

主要指标

Outcome:

dietary intake

Type:

Primary indicator

测量时间点:

诊断疾病前一年内

测量方法:

问卷调查

Measure time point of outcome:

within 1 year before diagnosis

Measure method:

questionnaire

指标中文名:

生活方式

指标类型:

次要指标

Outcome:

Lifestyle

Type:

Secondary indicator

测量时间点:

诊断疾病前

测量方法:

问卷调查

Measure time point of outcome:

before diagnosis

Measure method:

questionnaire

指标中文名:

保健品服用史

指标类型:

次要指标

Outcome:

Health supplement intake

Type:

Secondary indicator

测量时间点:

诊断疾病前一年内

测量方法:

问卷调查

Measure time point of outcome:

within 1 year before diagnosis

Measure method:

questionnaire

指标中文名:

睡眠情况

指标类型:

次要指标

Outcome:

Status of sleep

Type:

Secondary indicator

测量时间点:

诊断疾病前一个月内

测量方法:

问卷调查

Measure time point of outcome:

within 1 month before diagnosis

Measure method:

questionnaire

指标中文名:

生育史

指标类型:

次要指标

Outcome:

reproductive history

Type:

Secondary indicator

测量时间点:

测量方法:

问卷调查

Measure time point of outcome:

Measure method:

questionnaire

指标中文名:

吸烟史

指标类型:

次要指标

Outcome:

Smoking status

Type:

Secondary indicator

测量时间点:

诊断疾病前

测量方法:

问卷调查

Measure time point of outcome:

before diagnosis

Measure method:

questionnaire

指标中文名:

体力活动

指标类型:

次要指标

Outcome:

Physical activity

Type:

Secondary indicator

测量时间点:

诊断疾病前一个月内

测量方法:

问卷调查

Measure time point of outcome:

within 1 year before diagnosis

Measure method:

questionnaire

指标中文名:

疾病史

指标类型:

次要指标

Outcome:

History of physical illness

Type:

Secondary indicator

测量时间点:

诊断疾病前

测量方法:

问卷调查

Measure time point of outcome:

before diagnosis

Measure method:

questionnaire

指标中文名:

家族史

指标类型:

次要指标

Outcome:

Family history of physical illness

Type:

Secondary indicator

测量时间点:

测量方法:

问卷调查

Measure time point of outcome:

Measure method:

questionnaire

指标中文名:

单核苷酸多态性

指标类型:

主要指标

Outcome:

SNP

Type:

Primary indicator

测量时间点:

术前

测量方法:

血液

Measure time point of outcome:

before surgery

Measure method:

Blood

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 90 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):

队列研究:无随机

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

no random

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

N/A

Blinding:

N/A

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):

不公开

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

private

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:

不公开

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

private

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2019-12-20 21:10:42