Truedsson Mikael, Malm Johan, Barbara Sahlin K, Bugge May, Wieslander Elisabet, Dahlbäck Magnus, Appelqvist Roger, Fehniger Thomas E, Marko-Varga György
Örestadskliniken, Eddagatan 4, 217 67, Malmö, Sweden.
Section for Clinical Chemistry, Department of Translational Medicine, Lund University, Skåne University Hospital Malmö, 205 02, Malmö, Sweden.
Clin Transl Med. 2016 Mar;5(1):9. doi: 10.1186/s40169-016-0086-5. Epub 2016 Mar 7.
Chronic obstructive pulmonary disease (COPD) is an irreversible disease, diagnosed predominantly in smokers. COPD is currently the third leading cause of death worldwide. Far more than 15 % of smokers get COPD: in fact, most develop some amount of pulmonary impairment. Smoking-related COPD is associated with both acute exacerbations and is closely correlated to comorbidities, such as cardiovascular disease and lung cancer. The objective of our study (KOL-Örestad) is to identify biomarkers in smokers and ex-smokers, with early signs of COPD, and compare these biomarkers with those of non-smokers and healthy smokers/ex-smokers. The participants in the study are recruited from Örestadskliniken, a primary health care clinic in Malmö, Sweden.
Two hundred smokers and ex-smokers diagnosed with COPD with airflow restriction according to GOLD stages 1-4 will be included and compared with 50 healthy never-smokers, and 50 healthy smokers/ex-smokers without airflow restriction (total n = 300). The age distribution is 35-80 years. The participants undergo a health examination including medical history, smoking history, lung function measurements, and respond to a "Quality of Life" questionnaire. Blood samples are drawn every 6 months during a period of 5 years. Additional blood sample collection is performed if participants are experiencing an exacerbation. The blood fractions will be analyzed by standard clinical chemistry assays and by proteomics utilizing mass spectrometry platforms. Optimal sample integrity is ensured by rapid handling with robotic biobank processing followed by storage at -80 °C. The study has been approved by the Regional Ethical Review Board in Lund ( http://epn.se/en ), (Approval number: DNR 2013/480), and registered at the NIH clinical trial registry ( http://clinicaltrials.gov ).
Currently, 220 subjects are enrolled in the study.
The study design will enable discovery of new biomarkers by using novel mass spectrometric techniques that define early changes of COPD. Such panels of novel biomarkers may be able to distinguish COPD from closely related diseases, co-morbidities, and contribute to an increased understanding of these diseases. Graphical abstract KOL-Örestad Study.
慢性阻塞性肺疾病(COPD)是一种不可逆疾病,主要在吸烟者中被诊断出来。COPD目前是全球第三大死因。超过15%的吸烟者会患上COPD:事实上,大多数人会出现一定程度的肺功能损害。与吸烟相关的COPD既与急性加重有关,又与合并症密切相关,如心血管疾病和肺癌。我们的研究(KOL-Örestad)的目的是在有COPD早期迹象的吸烟者和已戒烟者中识别生物标志物,并将这些生物标志物与非吸烟者以及健康的吸烟者/已戒烟者的生物标志物进行比较。该研究的参与者从瑞典马尔默的一家初级医疗保健诊所Örestadskliniken招募。
将纳入200名根据GOLD 1-4期诊断为患有气流受限的COPD的吸烟者和已戒烟者,并与50名健康的从不吸烟者以及50名无气流受限的健康吸烟者/已戒烟者进行比较(总共n = 300)。年龄分布为35-80岁。参与者接受包括病史、吸烟史、肺功能测量在内的健康检查,并回答一份“生活质量”问卷。在5年期间每6个月采集一次血样。如果参与者病情加重,则进行额外的血样采集。血液成分将通过标准临床化学分析以及利用质谱平台的蛋白质组学进行分析。通过机器人生物样本库快速处理并随后储存在-80°C来确保最佳样本完整性。该研究已获得隆德地区伦理审查委员会(http://epn.se/en)批准(批准号:DNR 2013/480),并在国立卫生研究院临床试验注册中心(http://clinicaltrials.gov)注册。
目前,该研究已招募了220名受试者。
该研究设计将通过使用定义COPD早期变化的新型质谱技术来发现新的生物标志物。这样的新型生物标志物组可能能够将COPD与密切相关的疾病、合并症区分开来,并有助于增进对这些疾病的了解。图形摘要KOL-Örestad研究。