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注册号: Registration number: |
ChiCTR2600127130 |
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最近更新日期: Date of Last Refreshed on: |
2026-06-25 11:18:21 |
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注册时间: Date of Registration: |
2026-06-25 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
基于医院体检数据的民航从业人员20年回顾性健康队列构建研究 |
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Public title: |
Construction of a 20-Year Retrospective Health Cohort of Civil Aviation Practitioners Based on Hospital Physical Examination Data |
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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: |
基于医院体检数据的民航从业人员20年回顾性健康队列构建研究 |
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Scientific title: |
Construction of a 20-Year Retrospective Health Cohort of Civil Aviation Practitioners Based on Hospital Physical Examination Data |
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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: |
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申请注册联系人: |
任建君 |
研究负责人: |
任建君 |
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Applicant: |
JianjunRen |
Study leader: |
JianjunRen |
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申请注册联系人电话: Applicant telephone: |
+86 17311071815 |
研究负责人电话:
Study leader's |
+86 28 85421671 |
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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: |
niehongwei@wchscu.cn |
研究负责人电子邮件: Study leader's E-mail: |
juneent2016@163.com |
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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: |
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 |
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Applicant address: |
No. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan Province |
Study leader's address: |
#37 Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province |
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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: |
四川大学华西医院耳鼻咽喉头颈外科 |
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Applicant's institution: |
Department of Otorhinolaryngology, Head and Neck Surgery, West China Hospital, Sichuan University |
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研究负责人所在单位: |
四川大学华西医院 |
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Affiliation of the Leader: |
West China Hospital of Sichuan University |
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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: |
2026年审(1359)号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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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审查委员会 |
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Name of the ethic committee: |
Ethics Committee on Biomedical Research West China Hospital of Sichuan University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2026-06-16 00:00:00 | ||
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伦理委员会联系人: |
李娜 |
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Contact Name of the ethic committee: |
Lina |
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伦理委员会联系地址: |
四川省成都市武侯区国学巷37号 |
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Contact Address of the ethic committee: |
#37 Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 28 85422654 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
188974152@qq.com |
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研究实施负责(组长)单位: |
四川大学华西医院 |
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Primary sponsor: |
West China Hospital of Sichuan University |
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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 |
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Primary sponsor's address: |
#37 Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province |
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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: |
自选课题(自筹) |
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Source(s) of funding: |
Construction of a 20-Year Retrospective Health Cohort of Civil Aviation Practitioners Based on Hospi |
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研究疾病: |
高血压;糖尿病;血脂异常;肥胖;脂肪肝;高尿酸血症;肾损伤;心电图异常;甲状腺良性结节;内脏良性囊肿;睡眠障碍;恶性肿瘤 |
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Target disease: |
Hypertension; Diabetes mellitus; Dyslipidemia; Obesity; Fatty liver disease; Hyperuricemia; Renal injury; Electrocardiographic abnormalities; Benign thyroid nodules; Benign visceral cysts; Sleep disorders; Malignant tumors |
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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: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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研究目的: |
1.构建基于医院体检数据的民航从业人员25年回顾性健康队列。 2.描述不同岗位民航从业人员长期健康指标的分布特征和变化轨迹。 3.评估岗位类别、工龄及可获得的职业暴露因素与常见慢性病及体检异常的关联。 4.为后续前瞻性随访、风险预测模型建立及职业健康干预研究提供基础数据平台。 |
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Objectives of Study: |
To construct a 25-year retrospective health cohort of civil aviation practitioners based on hospital physical examination data.To describe the distribution characteristics and long-term changing trajectories of health indicators among civil aviation practitioners in different occupational posts.To evaluate the associations of occupational post type, working years and available occupational exposure factors with common chronic diseases and physical examination abnormalities.To establish a fundamental data platform for subsequent prospective follow-up, risk prediction model construction and occupational health intervention research. |
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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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纳入标准: |
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Inclusion criteria |
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排除标准: |
1.非民航从业人员。 |
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Exclusion criteria: |
1.Individuals who are not civil aviation practitioners. |
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研究实施时间: Study execute time: |
从 From 2026-06-01 00:00:00至 To 2028-12-22 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-06-25 00:00:00 至 To 2028-12-22 00:00:00 |
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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): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
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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 |
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盲法: |
无 |
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Blinding: |
None |
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是否共享原始数据: IPD sharing |
否No |
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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): |
不对外共享个体原始数据 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Individual-level raw data will not be shared externally. |
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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: |
采集 2001 年 1 月至 2026 年 1 月成都民用航空医学中心电子体检档案、电子病历;所有受试者信息完成去标识化脱敏处理;数据存储于医院内网加密数据库,设置分级访问权限,仅本课题授权人员可访问,留存完整操作日志,严格保护民航从业人员个人健康隐私。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Electronic physical examination archives and medical records from January 2001 to January 2026 of Chengdu Civil Aviation Medical Center are collected. All subject information is de-identified and desensitized. Data is stored in the hospital encrypted intranet database with hierarchical access permissions, only authorized researchers of this project have access, and complete operation logs are retained to strictly protect the personal health privacy of civil aviation practitioners. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |