title: Biomarkers of early chronic obstructive pulmonary disease (COPD) in smokers and former smokers. Protocol of a longitudinal study.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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 ).
  
  
  CONCLUSIONS
  Currently, 220 subjects are enrolled in the study.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Örestadskliniken, Eddagatan 4, 217 67, Malmö, Sweden. mikael.truedsson@orestadskliniken.com.
authors.forename: Mikael
authors.initials: M
authors.lastname: Truedsson
authors.affiliation: Section for Clinical Chemistry, Department of Translational Medicine, Lund University, Skåne University Hospital Malmö, 205 02, Malmö, Sweden. johan.malm@med.lu.se.|Centre of Excellence in Biological and Medical Mass Spectrometry, Biomedical Centre D13, Lund University, 221 84, Lund, Sweden. johan.malm@med.lu.se.
authors.forename: Johan
authors.initials: J
authors.lastname: Malm
authors.affiliation: Section for Clinical Chemistry, Department of Translational Medicine, Lund University, Skåne University Hospital Malmö, 205 02, Malmö, Sweden. barbara.sahlin@med.lu.se.|Centre of Excellence in Biological and Medical Mass Spectrometry, Biomedical Centre D13, Lund University, 221 84, Lund, Sweden. barbara.sahlin@med.lu.se.
authors.forename: K
authors.initials: K
authors.lastname: Barbara Sahlin
authors.affiliation: Örestadskliniken, Eddagatan 4, 217 67, Malmö, Sweden. may.bugge@orestadskliniken.com.
authors.forename: May
authors.initials: M
authors.lastname: Bugge
authors.affiliation: Centre of Excellence in Biological and Medical Mass Spectrometry, Biomedical Centre D13, Lund University, 221 84, Lund, Sweden. elisabet.wieslander@gmail.com.
authors.forename: Elisabet
authors.initials: E
authors.lastname: Wieslander
authors.affiliation: Centre of Excellence in Biological and Medical Mass Spectrometry, Biomedical Centre D13, Lund University, 221 84, Lund, Sweden. magnus.dahlback@bme.lth.se.|Clinical Protein Science and Imaging, Biomedical Centre, Department of Biomedical Engineering, BMC D13, Lund University, 221 84, Lund, Sweden. magnus.dahlback@bme.lth.se.
authors.forename: Magnus
authors.initials: M
authors.lastname: Dahlbäck
authors.affiliation: Centre of Excellence in Biological and Medical Mass Spectrometry, Biomedical Centre D13, Lund University, 221 84, Lund, Sweden. roger.appelqvist@bme.lth.se.|Clinical Protein Science and Imaging, Biomedical Centre, Department of Biomedical Engineering, BMC D13, Lund University, 221 84, Lund, Sweden. roger.appelqvist@bme.lth.se.
authors.forename: Roger
authors.initials: R
authors.lastname: Appelqvist
authors.affiliation: Centre of Excellence in Biological and Medical Mass Spectrometry, Biomedical Centre D13, Lund University, 221 84, Lund, Sweden.|Clinical Protein Science and Imaging, Biomedical Centre, Department of Biomedical Engineering, BMC D13, Lund University, 221 84, Lund, Sweden.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Fehniger
authors.affiliation: Centre of Excellence in Biological and Medical Mass Spectrometry, Biomedical Centre D13, Lund University, 221 84, Lund, Sweden. gyorgy.marko-varga@bme.lth.se.|Clinical Protein Science and Imaging, Biomedical Centre, Department of Biomedical Engineering, BMC D13, Lund University, 221 84, Lund, Sweden. gyorgy.marko-varga@bme.lth.se.|First Department of Surgery, Tokyo Medical University, 6-7-1 Nishishinjiku, Shinjiku-ku, Tokyo, 160-0023, Japan. gyorgy.marko-varga@bme.lth.se.
authors.forename: György
authors.initials: G
authors.lastname: Marko-Varga
keywords: Biobanking; Biomarkers; COPD; Clinical study; Proteomics