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山东省生长发育疾病随访研究队列
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注册号:

Registration number:

ChiCTR1900026510 

最近更新日期:

Date of Last Refreshed on:

2019-10-13 

注册时间:

Date of Registration:

2019-10-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

山东省生长发育疾病随访研究队列 

Public title:

Follow-up study of growth and development diseases in Shandong Province 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

山东省生长发育疾病随访研究队列 

Scientific title:

Follow-up study of growth and development diseases in Shandong Province 

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:

赵倩倩 

研究负责人:

班博 

Applicant:

Qiqnaiqn Zhao 

Study leader:

Bo Ban 

申请注册联系人电话:

Applicant telephone:

+86 14768729283 

研究负责人电话:

Study leader's telephone:

+86 18678760007 

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:

zhaoqian930915@163.com 

研究负责人电子邮件:

Study leader's E-mail:

banbo2011@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:

山东省济宁市古槐路89号 

研究负责人通讯地址:

山东省济宁市古槐路89号 

Applicant address:

89 Guhuai Road, Ji'ning, Shandong, China 

Study leader's address:

89 Guhuai Road, Ji'ning, Shandong, 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:

济宁医学院附属医院 

Applicant's institution:

Affiliated Hospital of Jining 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:

JYFY-2019-010 

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:

济宁医学院附属医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Affiliated Hospital of Jining Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-10 

伦理委员会联系人:

郑慧敏 

Contact Name of the ethic committee:

Huimin Zheng 

伦理委员会联系地址:

山东省济宁市古槐路89号 

Contact Address of the ethic committee:

89 Guhuai Road, Ji'ning, Shandong, 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:

济宁医学院附属医院 

Primary sponsor:

Affiliated Hospital of Jining Medical University 

研究实施负责(组长)单位地址:

山东省济宁市古槐路89号 

Primary sponsor's address:

89 Guhuai Road, Jining,Shandong, 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):

山东省

市(区县):

济宁市

Country:

China

Province:

Shandong

City:

Jining

单位(医院):

济宁医学院附属医院

具体地址:

山东省济宁市古槐路89号

Institution
hospital:

Affiliated Hospital of Jining Medical University

Address:

89 Guhuai Road, Jining,Shandong, China

经费或物资来源:

济宁市科技局 

Source(s) of funding:

Jining Science and Technology Bureau 

研究疾病:

下丘脑垂体疾病 

Target disease:

Hypothalamic pituitary disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health services reaserch 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

① 建立山东省生长发育疾病随访研究队列数据库,为后续进一步行病因及干预研究提供强有力的平台。 ②探讨更多影响生长发育疾病的影响因素,建立临床预测模型,为后续建立指导本地区、全省乃至全国的干预策略奠定一定的基础。 ③通过长期随访评估对rhGH治疗的监测,探讨其疗效和安全性,建立适合山东省儿童青少年的诊疗规范,为患者提供更合理的个性化治疗方案。 

Objectives of Study:

1. Establish a database of follow-up studies on growth and development diseases in Shandong Province, providing a powerful platform for further investigation of etiology and intervention; 2. To explore more influencing factors affecting growth and development diseases, and establish a clinical prediction model to lay a foundation for the follow-up to establish intervention strategies for the region, the province and even the whole country; 3. Through long-term follow-up evaluation of rhGH treatment monitoring, to explore its efficacy and safety, to establish a suitable medical treatment norms for children and adolescents in Shandong Province, to provide patients with more reasonable personalized treatment options. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

① 按骨龄身高标准差在-2SD以下 ②年龄3-18岁 ③或预测成年终身高偏矮(男性终身高<160cm,女性终身高<150cm) 

Inclusion criteria

1. The standard deviation according to the height of the bones is below -2 SD; 2. Aged 3-18 years; 3. the adult life expectancy is short (the male lifetime is <160cm, the female lifetime is <150cm). 

排除标准:

① 患有慢性肝肾功能不全、先天性心脏病、垂体肿瘤等器质性系统性疾病 ② 合并骨骼发育不良、染色体异常及其他遗传代谢性疾病。 

Exclusion criteria:

1. Chronic liver and kidney dysfunction, congenital heart disease, pituitary tumors and other organic systemic diseases; 2. combined with skeletal dysplasia, chromosomal abnormalities and other genetic metabolic diseases. 

研究实施时间:

Study execute time:

From2019-12-01To 2030-12-31 

征募观察对象时间:

Recruiting time:

From2019-12-01To 2029-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

3000

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):

山东省 

市(区县):

 

Country:

China 

Province:

Shandong Province 

City:

 

单位(医院):

济宁医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Jining Medical University  

Level of the institution:

Teriary A hospital 

测量指标:

Outcomes:

指标中文名:

身高

指标类型:

主要指标 

Outcome:

Height

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素样生长因子1

指标类型:

主要指标 

Outcome:

Insulin-like growth factor 1

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素样生长因子结合蛋白3

指标类型:

主要指标 

Outcome:

Insulin-like growth factor binding protein 3

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨龄

指标类型:

主要指标 

Outcome:

bone age

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生长激素峰值

指标类型:

主要指标 

Outcome:

Growth hormone peak

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

其它相关实验室指标

指标类型:

次要指标 

Outcome:

Other relevant laboratory indicators

Type:

Secondary 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 3 years
最大 Max age 18 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

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

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):

试验完成后6个月内公开;通过ResMan查询, http://www.medresman.org.

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

Within six months after the trial complete;IPD will be accessed via ResMan, http://www.medresman.org.

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:

数据采集和管理采用CRF+EDC的方式进行

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

Data collection and management includes a CRF+EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-13
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