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：	ChiCTR2500106569
最近更新日期： Date of Last Refreshed on：	2025-07-25 15:27:11
注册时间： Date of Registration：	2025-07-25 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	COPD患者BALF中潜在生物标志物探索研究
Public title：	Exploratory study on potential biomarkers in BALF of COPD patients
注册题目简写：
English Acronym：
研究课题的正式科学名称：	COPD患者BALF中潜在生物标志物探索研究
Scientific title：	Exploratory study on potential biomarkers in BALF of COPD patients
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：	耿爽	研究负责人：	耿爽
Applicant：	Shuang Geng	Study leader：	Shuang Geng
申请注册联系人电话： Applicant telephone：	+86 13476192468	研究负责人电话： Study leader's telephone：	+86 27 65699802
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：	gengshuangsky@126.com	研究负责人电子邮件： Study leader's E-mail：	gengshuangsky@126.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：	武汉市江岸区胜利街26号	研究负责人通讯地址：	武汉市江岸区胜利街26号
Applicant address：	No. 26 Shengli Street, Jiangan District, 430014 Wuhan, China	Study leader's address：	No. 26 Shengli Street, Jiangan District, 430014 Wuhan, 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：	武汉市中心医院
Applicant's institution：	The Central Hospital of Wuhan
研究负责人所在单位：	武汉市中心医院
Affiliation of the Leader：	The Central Hospital of Wuhan

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：	WHZXKYL2024-208	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：	武汉市中心医院伦理委员会
Name of the ethic committee：	Ethics Committee of The Central Hospital of Wuhan
伦理委员会批准日期： Date of approved by ethic committee：	2024-09-30 00:00:00
伦理委员会联系人：	石小燕
Contact Name of the ethic committee：	Shi XiaoYan
伦理委员会联系地址：	武汉市江岸区胜利街26号
Contact Address of the ethic committee：	No. 26 Shengli Street, Jiangan District, 430014 Wuhan, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 27 82223802	伦理委员会联系人邮箱： Contact email of the ethic committee：	sxy_70@sina.com.cn

研究实施负责（组长）单位：

武汉市中心医院

Primary sponsor：

The Central Hospital of Wuhan

研究实施负责（组长）单位地址：

武汉市江岸区胜利街26号

Primary sponsor's address：

No. 26 Shengli Street, Jiangan District, 430014 Wuhan, 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)：	湖北省	市(区县)：
Country：	China	Province：	Hubei	City：
单位(医院)：	武汉市中心医院	具体地址：	武汉市江岸区胜利街26号
Institution hospital：	The Central Hospital of Wuhan	Address：	No. 26 Shengli Street, Jiangan District, 430014 Wuhan, China

经费或物资来源：

武汉市生物样本有限公司

Source(s) of funding：

Wuhan Biological Sample Co., Ltd

研究疾病：

慢性阻塞性肺疾病

Target disease：

COPD

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：

析因分组（即根据危险因素或暴露因素分组）

Study design：

Factorial

研究目的：

本研究拟收集COPD患者和健康对照人群的生物样本及信息，采用标准化样本处理和存储流程，主要通过Olink技术、ELISA技术和质谱技术等，探索COPD患者BALF及血液中潜在生物标志物，为COPD的相关转化医学研究提供数据基础和理论依据

Objectives of Study：

This study aims to collect biological samples and information from COPD patients and healthy control groups, utilizing standardized sample processing and storage procedures. Primarily, it explores potential biomarkers in the BALF and blood of COPD patients through Olink technology, ELISA technology, and mass spectrometry technology, providing a data foundation and theoretical basis for related translational medical research on COPD

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. Inclusion criteria for COPD patients: (1) 40-80 years old (including upper and lower limits), male or female; (2) Currently smoking, or having never smoked, or a smoker (who has quit smoking for more than 6 months at the time of screening and has a smoking history of 10 packs per year or more); (3) According to the GOLD (Global Initiative for Chronic Obstructive Pulmonary Disease) guidelines, subjects diagnosed with COPD for more than 12 months prior to screening; (4) Before screening, the FEVI of subjects using bronchodilators accounted for ≥ 30% of the expected value (GOLD I-II).
2. Inclusion criteria for healthy control population: (1) Age range of 40-80 years old; (2) Subjects undergoing elective surgery, such as hernia repair, plastic surgery, benign skin mass resection, etc; Perform lung function before surgery Ability to perform lung CT, electrocardiogram, whole blood cell count, and biochemical analysis; (3) Four weeks prior to inclusion in the study, there were no respiratory symptoms such as fever, runny nose, nasal congestion, cough, sputum production, wheezing, chest pain, etc Hemoptysis, etc; (4) There were no clinical infections in the three months prior to inclusion in the study; Have not used oral/nasal antibiotics/antifungal drugs/antiviral drugs in the past 3 months Toxic drugs; (5) Research participants or their family members voluntarily participate and sign an informed consent form;

排除标准：

1.COPD 患者排除标准（1）孕妇，或正处于哺乳期；（2）筛选前1年内进行过肺切除/肺减容/肺移植手术；（3）筛选前4周内发生呼吸道感染，或使用过抗生素、全身性皮质类固醇以及茶碱；（4）严重肝/肾功能不全；（5）具有免疫缺陷病史（先天性免疫缺陷、HIV 感染等）；（6）筛选前4周内受试者发生 COPD 急性加重；（7）筛选前3个月内曾参加过其他临床试验，或筛选前仍处于上一个药物临床试验规定的安全性洗脱期内（＜5个半衰期）者，以时间较长者为准；（8） 5年内患有恶性肿瘤；（9）既往有除 COPD 以外具有显著临床意义的肺部异常/疾病（活动性结节病、支气管扩张、肺纤维化、间质性肺炎等）。
2.健康对照人群排除标准符合以下任何一条的患者将不能人选本研究：（1）有吸烟史；（2）患有由口腔专科医生诊断的严重的牙周疾病；（3）鼻腔术后（53个月），外腔内肿物、严重畸形者；（4）支气管哮喘持续状态、肺功能严重障碍或无法耐受支气管镜检查的受试者；（5）肺部CT检查异常：囊性纤维化、有临床意义的支气管扩张、纤维化性肺病或其他慢性肺部疾病；（6）患有胃食管反流病、消化性溃疡；6月内服用益生菌；（7）有明显的出血倾向、严重肺动脉高压、上腔静脉阻塞、主动脉瘤有破裂危险的患者；（8）恶性高血压、近期发生的心肌梗死（≤6 个月）、严重的心律失常、心功能不全的患者；（9）患有糖尿病、自身免疫性疾病、恶性肿瘤性疾病、先天或获得性免疫缺陷病、其他全身炎症反应类疾病；（10）期接受高风险免疫抑制/细胞蒜性药物治疗者，例如利妥昔单抗、阿𩆨素或类固醇激素持续应用4周以上；（11）妊娠或脯乳期；（12）有精神功能不全或活动性精神疾病妨碍知情同意；（13）其他临床医师判定不适合人选研究的情况.孕妇，或正处于哺乳期。

Exclusion criteria：

1.Exclusion criteria for COPD patients: (1) Pregnant or breastfeeding; (2) Having undergone lung resection/lung volume reduction/lung transplantation surgery within the previous year prior to screening; (3) Respiratory infections occurred within the first 4 weeks of screening, or antibiotics, systemic corticosteroids, and theophylline were used; (4) Severe liver/kidney dysfunction; (5) History of immunodeficiency (congenital immunodeficiency, HIV infection, etc.); (6) The subject experienced acute exacerbation of COPD within 4 weeks prior to screening; (7) Those who have participated in other clinical trials within the previous 3 months before screening, or are still within the safety washout period (<5 half lives) specified in the previous drug clinical trial before screening, whichever is longer; (8) Suffering from malignant tumors within 5 years; (9) Previous pulmonary abnormalities/diseases with significant clinical significance other than COPD (active sarcoidosis, bronchiectasis, pulmonary fibrosis, interstitial pneumonia, etc.).
2.Exclusion criteria for healthy control population Patients who meet any of the following criteria will not be eligible for this study: (1) Have a history of smoking; (2) Suffering from severe periodontal disease diagnosed by a dental specialist; (3) After nasal cavity surgery (53 months), patients with external cavity tumors and severe deformities; (4) Subjects with persistent bronchial asthma, severe pulmonary dysfunction, or inability to tolerate bronchoscopy examination; (5) Abnormal lung CT examination: cystic fibrosis, clinically significant bronchiectasis, fibrotic lung disease or other Chronic lung disease; (6) Suffering from gastroesophageal reflux disease and peptic ulcer; Take probiotics within 6 months; (7) Patients with obvious bleeding tendency, severe pulmonary hypertension, superior vena cava obstruction, and risk of aortic aneurysm rupture; (8) Patients with malignant hypertension, recent myocardial infarction (≤ 6 months), severe arrhythmia, and cardiac dysfunction; (9) Suffering from diabetes, autoimmune disease, malignant tumor disease, congenital or acquired immunodeficiency disease, others Systemic inflammatory response diseases; (10) Individuals undergoing high-risk immunosuppressive/cellular garlic drug therapy, such as rituximab, avidin, or steroids Continuous use of hormones for more than 4 weeks; (11) Pregnancy or lactation period; (12) Having impaired mental function or active mental illness that hinders informed consent; (13) Other clinical physicians determine that the candidate is not suitable for the study Pregnant women or currently breastfeeding.

研究实施时间：

Study execute time：

从 From 2024-09-01 00:00:00至 To 2026-09-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-11-06 00:00:00 至 To 2026-09-30 00:00:00

干预措施：

Interventions：

组别：	健康对照组	样本量：	15
Group：	Healthy control group	Sample size：	15
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	COPD组	样本量：	15
Group：	COPD group	Sample size：	15
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)：	湖北省	市(区县)：
Country：	China	Province：	Hubei	City：
单位(医院)：	武汉市中心医院	单位级别：	三级甲等
Institution hospital：	The Central Hospital of Wuhan	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	肺泡灌洗液及血液中生物标记物	指标类型：	主要指标
Outcome：	Biomarkers in bronchoalveolar lavage fluid	Type：	Primary indicator
测量时间点：	受试者生物样本采集结束4小时内	测量方法：	1. Olink炎症因子谱检测检测BALF及血液中潜在生物标志物；2. ELISA 检测检测BALF及血液中潜在生物标志物
Measure time point of outcome：	Within 4 hours after the completion of the collection of biological samples from the subjects	Measure method：	Detecting the levels of potential biomarkers in BALF and blood by Olink;Detecting the levels of potential biomarkers in BALF and blood by ELISA

指标中文名：	溶血性磷脂酰胆碱检测	指标类型：	主要指标
Outcome：	Hemolytic phosphatidylcholine detection	Type：	Primary indicator
测量时间点：	受试者生物样本采集结束4小时内	测量方法：	溶血性磷脂酰胆碱检测
Measure time point of outcome：	Within 4 hours after the completion of the collection of biological samples from the subjects	Measure method：	Hemolytic phosphatidylcholine detection

指标中文名：	肺泡灌洗液上清进行蛋白定量	指标类型：	主要指标
Outcome：	Protein quantification of alveolar lavage fluid supernatant	Type：	Primary indicator
测量时间点：	受试者生物样本采集结束4小时内	测量方法：	BCA总蛋白定量
Measure time point of outcome：	Within 4 hours after the completion of the collection of biological samples from the subjects	Measure method：	BCA Total Protein Quantification

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：	肺泡灌洗液	组织：
Sample Name：	BALF	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	40	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:

不公开/Private

盲法：	无
Blinding：	None

是否共享原始数据： IPD sharing	是Yes
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）：	数据需在项目结束后第3年方可申请。数据需向武汉市生物样本库有限公司提交申请单，依据武汉生物样本库有限公司数据使用管理办法及立项方案内有关数据相关协议进行申请，需经项目管理员同意审批后方可获取。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The data can only be applied for in the third year after the project is completed. The data needs to be submitted to Wuhan Biological Sample Bank Co., Ltd. as an application form, in accordance with the data usage management measures of Wuhan Biological Sample Bank Co., Ltd. and the relevant data related agreements in the project proposal. Approval from the project administrator is required before obtaining the data.
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：	a.武汉生物样本数据采集武汉市中心医院呼吸与危重症医学科工作人员负责样本及相关数据采集，武汉市中心医院生物样本库工作人员将入组研究参与者唯一项目编码和住院号录入生物样本信息管理系统中。武汉生物样本库工作人员利用入组研究参与者唯一项目编码对样本进行管理，利用住院号向医院申请数据，提取脱敏(姓名、家庭住址、身份证号等隐私信息)后的临床数据并存入经IP guard加密的移动硬盘。整个过程均在《样本数据签收表》中进行记录。数据转移至武汉生物样本库后，工作人员对数据进行清洗入库并填写《样本信息录入登记表》。通过入组患者唯一项目编码和住院号的关系，实现样本和临床数据的关联，武汉生物样本库不存储个人标识数据(如姓名、身份证号码、家庭住址、电话号码),且所有数据均由数据库加密软件保存至数据库。 b.武汉生物样本库数据入库及清洗数据经加密硬盘转移至武汉生物样本库后即进行数据的清洗动作，入库时需再次对数据进行核对，如数据的条数、是否脱敏等，确认无误后录入通过三级等保评审的样本管理系统并记录至《样本信息的录入登记表》。同时系统采用本地+异地备份的方式以保障数据的安全行与可靠性。数据清洗时，根据国家标准《信息安全技术健康医疗数据安全指南》要求，须对关键信息如年龄、住院号等进行“数据泛化”处理。 c.武汉生物样本库数据使用管理武汉生物样本库根据数据最小化原则，利用临床研究及随访平台对研究所需的样本数据、临床数据和研究过程中产生的检测数据进行标准化管理，工作人员分角色授权查看研究必须的字段数据；数据导出需要在临床研究及随访平台进行在线申请，申请单需要包含数据条数、每条数据包含变量和申请原因，由授权的项目管理员进行审批，审批完成后方可下载，并记录下载次数。此外，武汉生物样本库和下游药物研发机构在合作协议中约定保密条款，约束双方合法使用本项目资料文件的行为。武汉生物样本库仅提供检测样本的去标识化的人口学信息、诊断、既往史、用药情况、体格检查、实验室检验信息和基于样本检测产生的结果数据，双方签署《样本数据签收表》,并由IPguard加密硬盘进行数据的传输，下游药物研发机构在本研究过程中不接触到任何有关研究参与者的个人敏感信息和相关实体样本。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The staff of the Respiratory and Critical Care Medicine Department of Wuhan Central Hospital are responsible for sample and related data collection. The staff of the Wuhan Central Hospital Biological Sample Library will enter the unique project codes and hospitalization numbers of the enrolled research participants into the biological sample information management system. The staff of Wuhan Biological Sample Library managed the samples using the unique project code of the enrolled research participants, applied for data from the hospital using the hospitalization number, extracted the desensitized clinical data (name, home address, ID number and other private information) and stored it in the mobile hard disk encrypted by IP guard. The entire process is recorded in the 'Sample Data Receipt Form'. After the data was transferred to the Wuhan Biological Sample Library, the staff cleaned and stored the data, and filled out the "Sample Information Input Registration Form". The association between samples and clinical data is realized through the relationship between the unique item code and hospitalization number of enrolled patients. Wuhan Biological Sample Database does not store personal identification data (such as name, ID card number, home address, telephone number), and all data are saved to the database by database encryption software. b. Data storage and cleaning of Wuhan Biological Sample Library After the data is transferred to the Wuhan Biological Sample Library through encrypted hard drives, the data is immediately cleaned. When it is stored, the data needs to be checked again, such as the number of data items and whether they have been desensitized. After confirming that there are no errors, it is entered into the sample management system that has passed the three-level security review and recorded in the "Sample Information Input Registration Form". At the same time, the system adopts a local+remote backup approach to ensure the security and reliability of data. When cleaning data, according to the national standard "Guidelines for Health and Medical Data Security in Information Security Technology", key information such as age and hospitalization number must be subjected to "data generalization" processing. c. Data usage management of Wuhan Biological Sample Bank According to the principle of data minimization, the Wuhan Biological Sample Library uses clinical research and follow-up platforms to standardize the management of sample data, clinical data, and detection data generated during the research process. Staff members are authorized to view necessary field data for the research based on their roles; The data export needs to be applied for online on the clinical research and follow-up platform. The application form should include the number of data items, variables included in each data item, and the reason for the application. It should be approved by an authorized project administrator before it can be downloaded, and the number of downloads should be recorded. In addition, the Wuhan Biological Sample Bank and downstream drug research and development institutions have agreed on confidentiality clauses in the cooperation agreement to constrain both parties' lawful use of the project's information and documents. The Wuhan Biological Sample Library only provides de identified demographic information, diagnosis, medical history, medication use, physical examination, laboratory testing information, and result data based on sample testing. Both parties sign the "Sample Data Receipt Form" and the data is transmitted through IPguard encrypted hard drive. Downstream drug research and development institutions do not come into contact with any sensitive personal information or related physical samples of research participants during this study.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-07-25 15:26:46