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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2500114590 |
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最近更新日期: Date of Last Refreshed on: |
2026-01-13 17:51:08 |
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注册时间: Date of Registration: |
2025-12-15 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: |
社区重大慢性心肺共病的临床流行病学特 征与医疗卫生服务质量评估:一项关联性研究 |
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Public title: |
Chronic Cardio-Pulmonary Comorbidity in the Chinese Community Health Center-A Clinical Epidemiological Analysis from Dual Quality Perspectives (CPCC-Q2) |
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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: |
社区重大慢性心肺共病的临床流行病学特 征与医疗卫生服务质量评估:一项关联性研究 |
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Scientific title: |
Chronic Cardio-Pulmonary Comorbidity in the Chinese Community Health Center-A Clinical Epidemiological Analysis from Dual Quality Perspectives (CPCC-Q2) |
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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: |
程玉 |
研究负责人: |
沈灿 |
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Applicant: |
Cheng Yu |
Study leader: |
Shen Can |
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申请注册联系人电话: Applicant telephone: |
+86 158 8114 6915 |
研究负责人电话:
Study leader's |
+86 182 8016 2561 |
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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: |
1653013920@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
171265186@qq.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 Alley, Wuhou District, Chengdu, Sichuan, China |
Study leader's address: |
No. 37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, China |
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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 |
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Applicant's institution: |
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, 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: |
2025年审(2197) 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?学华西医院?物医学伦理审查委员会 |
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Name of the ethic committee: |
Biomedical Research Ethics Committee of West China Hospital, Sichuan University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-11-28 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: |
Li Na |
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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: |
No. 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan Province |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 28 8542 2654 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
hxlcyjglb@163.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, 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: |
No. 37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, 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: |
无 |
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Source(s) of funding: |
None |
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研究疾病: |
社区重大慢性心肺共病 |
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Target disease: |
Major Chronic Cardio-Pulmonary Comorbidities in the Community |
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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: |
连续入组 |
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Study design: |
Sequential |
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研究目的: |
揭示我国人群中CPD的流行病学现状与分布特征;系统识别并量化导致CPD发生与发展的关键危险因素;评估社区CPD的医疗服务质量。 |
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Objectives of Study: |
To elucidate the epidemiological status and distribution characteristics of CPD in the Chinese population; to systematically identify and quantify the key risk factors contributing to the onset and progression of CPD; and to evaluate the quality of healthcare services for CPD at the community level. |
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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: |
年龄≥18 岁;在所选社区卫生服务中心建立健康档案(即接受家庭医生签约服务的对象);自愿参加本研究并签署知情同意书。 |
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Inclusion criteria |
Aged >=18 years; having a health record established at the selected community health service centers (i.e., enrolled in family doctor contracted services); and voluntarily participating in the study with signed informed consent. |
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排除标准: |
患有严重认知障碍、精神疾病或沟通障碍,无法完成问卷调查;合并其他预期生存时间<1年的恶性疾病(如晚期癌症);计划迁出本地区,无法完成随访。 |
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Exclusion criteria: |
Having severe cognitive impairment, psychiatric disorders, or communication barriers that prevent completion of the questionnaire; having coexisting malignant diseases with an expected survival of less than one year (e.g., advanced cancer); or planning to relocate out of the area, making follow-up impossible. |
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研究实施时间: Study execute time: |
从 From 2025-12-01 00:00:00至 To 2031-01-01 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-12-23 00:00:00 至 To 2031-01-01 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: |
公开/Public |
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盲法: |
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Blinding: |
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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 |
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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): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
none |
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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: |
数据采集和管理使用电子采集和管理系统,使用全科科研病种库网站https://mrd.cd120.com/edc/#/login,数据管理由四川大学华西医院信息科进行管理 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Data collection and management were conducted using an electronic data capture and management system, specifically the General Practice Research Disease Registry platform ([https://mrd.cd120.com/edc/#/login](https://mrd.cd120.com/edc/#/login)). Data management was overseen by the Information Technology Department of West China Hospital, Sichuan University. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |