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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
济宁医学院附属医院 |
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Applicant's institution: |
Affiliated Hospital of Jining Medical University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Ethics Committee of Affiliated Hospital of Jining Medical University |
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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 |
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Contact Name of the ethic committee: |
Huimin Zheng |
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伦理委员会联系地址: |
山东省济宁市古槐路89号 |
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Contact Address of the ethic committee: |
89 Guhuai Road, Ji'ning, Shandong, China |
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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 |
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Primary sponsor: |
Affiliated Hospital of Jining Medical University |
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研究实施负责(组长)单位地址: |
山东省济宁市古槐路89号 |
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Primary sponsor's address: |
89 Guhuai Road, Jining,Shandong, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
济宁市科技局 |
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Source(s) of funding: |
Jining Science and Technology Bureau |
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研究疾病: |
下丘脑垂体疾病 |
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Target disease: |
Hypothalamic pituitary disease |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
卫生服务研究 |
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Study type: |
Health services reaserch |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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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。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
单臂 |
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Study design: |
Single arm |
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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) |
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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). |
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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。 |
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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: |
从From2019-12-01至To 2030-12-31 |
征募观察对象时间: Recruiting time: |
从From2019-12-01至To 2029-12-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
N/A |
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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): |
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Calculated Results after
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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 |