中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400095045
最近更新日期： Date of Last Refreshed on：	2024-12-31 16:50:25
注册时间： Date of Registration：	2024-12-31 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	COPD共病集成队列建立、评估及相关免疫机制研究
Public title：	Establishment, Evaluation and Related Immune Mechanism Research of Integrated COPD Co-morbidity Cohort
注册题目简写：
English Acronym：
研究课题的正式科学名称：	COPD共病集成队列建立、评估及相关免疫机制研究
Scientific title：	Establishment, Evaluation and Related Immune Mechanism Research of Integrated COPD Co-morbidity Cohort
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：	李莉芳	研究负责人：	赵卉
Applicant：	Li Lifang	Study leader：	Zhao Hui
申请注册联系人电话： Applicant telephone：	+86 139 9425 2152	研究负责人电话： Study leader's telephone：	+86 138 3517 5536
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：	Lilf9717@163.com	研究负责人电子邮件： Study leader's E-mail：	Zhaohui001@sina.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：	山西省太原市杏花岭区五一路382号	研究负责人通讯地址：	山西省太原市杏花岭区五一路382号
Applicant address：	No. 382, Wuyi Road, XinghuaLing District, Taiyuan City, Shanxi Province.	Study leader's address：	No. 382, Wuyi Road, XinghuaLing District, Taiyuan City, Shanxi Province.
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：	山西医科大学第二医院
Applicant's institution：	The Second Hospital of Shanxi Medical University
研究负责人所在单位：	山西医科大学第二医院
Affiliation of the Leader：	The Second Hospital of Shanxi 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：	[2024]YX 第444号	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：	山西医科大学第二医院伦理委员会
Name of the ethic committee：	Ethics Committee of the Second Hospital of Shanxi Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2024-10-30 00:00:00
伦理委员会联系人：	高瑾
Contact Name of the ethic committee：	Gao Jin
伦理委员会联系地址：	山西省太原市杏花岭区五一路382号
Contact Address of the ethic committee：	No. 382, Wuyi Road, XinghuaLing District, Taiyuan City, Shanxi Province.
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 351 336 3698	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：

山西医科大学第二医院

Primary sponsor：

The Second Hospital of Shanxi Medical University

研究实施负责（组长）单位地址：

山西省太原市杏花岭区五一路382号

Primary sponsor's address：

No. 382, Wuyi Road, XinghuaLing District, Taiyuan City, Shanxi Province.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	山西省	市(区县)：	太原市
Country：	China	Province：	Shanxi Province	City：	Taiyuan City
单位(医院)：	山西医科大学	具体地址：	山西省晋中市大学街98号
Institution hospital：	Shanxi Medical University	Address：	98 University Street, Jinzhong City, Shanxi Province

经费或物资来源：

山西省高等教育“百亿工程”项目（BY-ZB-2024007）

Source(s) of funding：

"Hundred Billion Project" for Higher Education in Shanxi Province (BY-ZB-2024007)

研究疾病：

慢性阻塞性肺疾病

Target disease：

Chronic obstructive pulmonary disease

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：

连续入组

Study design：

Sequential

研究目的：

本研究为前瞻性的真实世界研究，通过调查COPD共病患者的诊疗现状，进而通过数据挖掘技术和统计建模，研究COPD可能影响因素的整体效应，考察COPD高危人群分布特征，构建COPD风险评估系统，筛选出“高危人群”；整合COPD多组学数据，创新性地构建最优化整合框架模型，构建系列增强融合整合分型方法，最终建立多组学数据整合分型的新方法体系。

Objectives of Study：

This study is a prospective real-world research. By investigating the current diagnosis and treatment status of patients with COPD comorbidities, it aims to explore the overall effects of potential influencing factors of COPD through data mining techniques and statistical modeling, examine the distribution characteristics of high-risk groups for COPD, and establish a COPD risk assessment system to identify "high-risk groups". It also integrates multi-omics data of COPD, innovatively constructs an optimized integration framework model, and develops a series of enhanced fusion and integration classification methods, ultimately establishing a new method system for the integration and classification of multi-omics data.

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

1. Patients with COPD and lung cancer: no age limit, no gender limit; Patients with suspected or confirmed diagnosis of COPD (pulmonary function tests are required for the diagnosis, FEV1/FVC <70% after expansion) and the diagnosis of primary lung cancer is confirmed by histopathological examinations such as surgical resection of specimens, bronchoscopic fine needle aspiration or percutaneous lung biopsy tissue; Subjects voluntarily participate in this clinical trial and sign the informed consent form. The investigator judges that the subject's compliance meets the requirements of this study.
2. Patients with COPD and sleep apnea (OSA): patients over 18 years old, regardless of race or gender; Patients diagnosed with COPD (dilated FEV1/FVC <70%) by pulmonary function tests in our hospital, and patients diagnosed with OSA by overnight monitoring by polysomnography (Embla N7000 multi-conductive series made in the United States); The patient voluntarily signed the informed consent form and was able to cooperate with the follow-up according to his requirements.
3. Patients with COPD and pulmonary interstitial fibrosis: COPD combined with pulmonary interstitial fibrosis (determined by experienced respiratory specialists and imaging specialists).
4. Patients with acute exacerbation of COPD complicated with anxiety and depression: confirmed chronic obstructive pulmonary disease (COPD): patients diagnosed with COPD according to the criteria of the Global Initiative (GOLD) or the American Thoracic Society (ATS). between 18 and 80 years old; Able to understand the content of the study and sign the informed consent form: Participants should have sufficient cognitive ability to understand the purpose and process of the study, and participate voluntarily. Able to cooperate with the assessment and follow-up required to complete the study: including pulmonary function tests, psychological assessments, questionnaires, etc.

排除标准：

1.COPD合并肺癌患者：严重精神或神经系统疾患，影响知情同意和/或不良反应表述或观察；转移性肺癌；无法完成首次问卷填写及进行肺功能检查；正在参与其他药物临床试验或干预性研究的受试者。 2.COPD合并睡眠呼吸暂停（OSA）患者：严重精神或神经系统疾患，影响知情同意和/或不良反应表述或观察；无法完成首次问卷填写及进行肺功能检查；正在参与其他药物临床试验或干预性研究的受试者。 3.COPD合并肺间质纤维化患者：结缔组织病或血管炎相关肺间质纤维化；合并肿瘤且经放疗或靶向治疗或免疫治疗、胺碘酮、博来霉素等治疗后出现的相关肺间质纤维化；职业粉尘导致的肺间质纤维化；结节病等病因明确的肺间质纤维化。 4.COPD急性加重期合并焦虑抑郁患者：其他严重心肺疾病：如重度心脏病、肺纤维化等；精神疾病史，和有其他严重精神疾病史的患者，正在接受抗焦虑或抗抑郁治疗的患者；正在使用可能引起精神症状的药物的患者；无法配合完成研究所需的评估和随访：包括无法理解研究内容、无法按时参加评估和随访等情况；其他可能影响研究结果的因素：如酗酒、药物滥用等。

Exclusion criteria：

1. Patients with COPD and lung cancer: severe mental or neurological disorders that affect informed consent and/or adverse reaction expression or observation; metastatic lung cancer; Inability to complete the first questionnaire and perform pulmonary function tests; Subjects who are participating in other drug clinical trials or interventional studies. 2. Patients with COPD and sleep apnea (OSA): severe psychiatric or neurological disorders that affect informed consent and/or adverse reaction expression or observation; Inability to complete the first questionnaire and perform pulmonary function tests; Subjects who are participating in other drug clinical trials or interventional studies. 3. Patients with COPD and pulmonary interstitial fibrosis: pulmonary interstitial fibrosis associated with connective tissue disease or vasculitis; Related pulmonary interstitial fibrosis with tumor and treated with radiotherapy or targeted therapy or immunotherapy, amiodarone, bleomycin, etc.; interstitial pulmonary fibrosis caused by occupational dust; Sarcoidosis and other pulmonary interstitial fibrosis of clear etiology. 4. Patients with acute exacerbation of COPD combined with anxiety and depression: other serious cardiopulmonary diseases: such as severe heart disease, pulmonary fibrosis, etc.; Patients with a history of psychiatric illness, and patients with a history of other serious psychiatric disorders, patients who are receiving anti-anxiety or antidepressant therapy; Patients who are using medications that may cause psychiatric symptoms; Inability to cooperate with the assessment and follow-up required to complete the study: including inability to understand the content of the study, inability to participate in the assessment and follow-up on time, etc.; Other factors that may affect the results of the study: such as alcoholism, drug abuse, etc.

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2030-01-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-01-01 00:00:00 至 To 2030-01-01 00:00:00

干预措施：

Interventions：

组别：	观察组	样本量：	200
Group：	Observation group	Sample size：	200
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山西	市(区县)：
Country：	China	Province：	Shanxi	City：
单位(医院)：	山西医科大学第二医院	单位级别：	三甲
Institution hospital：	The Second Hospital of Shanxi Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	慢阻肺不同合并症在随访期间内的全因死亡率	指标类型：	主要指标
Outcome：	All-cause mortality of different COPD comorbidities during follow-up	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	慢阻肺不同合并症的患者在随访结束时肺功能、生活质量变化情况	指标类型：	次要指标
Outcome：	Changes of lung function and quality of life in patients with different COPD complications at the end of follow-up	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	描述真实世界中慢阻肺不同合并症的患者的药物治疗现状	指标类型：	次要指标
Outcome：	Describe the current status of drug treatment in patients with different COPD comorbidities in the real world	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	比较真实世界中慢阻肺不同合并症管理模式与指南的差异	指标类型：	次要指标
Outcome：	To compare the differences of management models and guidelines for COPD complications in the real world	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	慢阻肺不同合并症的风险评估体系	指标类型：	次要指标
Outcome：	Risk assessment system of different COPD complications	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	慢阻肺患者在随访期间每年平均直接医疗费用	指标类型：	次要指标
Outcome：	Average direct medical costs per year for COPD patients during follow-up	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	不同治疗方案的成本/效果分析	指标类型：	次要指标
Outcome：	Cost/effectiveness analysis of different treatment options	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：

标本中文名：	痰液	组织：
Sample Name：	Sputum	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	支气管肺泡灌洗液	组织：
Sample Name：	Bronchoalveolar lavage fluid	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	岁 years
最大 Max age	80	岁 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）：

无

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

None

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

盲法：	无
Blinding：	None
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
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：	CRF;EDC
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	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：	2024-12-31 16:49:06