Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) in Smokers - Longitudinal Study

NCT02076061 | Completed

• 1 other identifier: KOL 001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a longitudinal observational study to identify and validate protein biomarkers for COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and ex-smokers attending primary care. Special emphasize is to correlate biomarkers to different phases of COPD, to progression of the disease, and to treatment of the disease. Furthermore, linkage between COPD, cardiovascular disease, and lung cancer will be investigated by identifying protein biomarkers.

Conditions

Chronic Obstructive Pulmonary Disease; Cardiovascular Disease; Lung Cancer

Keywords

COPD; Primary Care; Smoking; Smokers; ex-Smokers; Lung Cancer; Cardiovascular Disease; Proteomics; Biomarkers; Biobank; Disease Staging; Gold Stage

Outcome Measures

Primary Outcomes (1)

• Advanced disease etiology requiring hospitalization.

  2 years

Study Arms (6)

GOLD stage I

GOLD Stage II

GOLD Stage III

GOLD Stage IV

Smokers/ex-smokers w/o COPD

non-Smokers w/o COPD

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic in Malmö, Sweden

You may qualify if:

• Diagnosed with COPD Gold stage 0-IV

You may not qualify if:

• Patients with inflammatory diseases Patients with cancer Patients using immune system regulating drugs

Sponsors & Collaborators

• Lund University: lead
• Örestadskliniken: collaborator

Study Sites (1)

Örestadskliniken

Malmo, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Lung Neoplasms; Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Behavior; Health Behavior

Study Officials

• Johan Malm

  Clincal Chemistry, Lund University

  STUDY CHAIR

• György Marko-Varga

  Clinical Protein Science & Imaging, Lund University

  PRINCIPAL INVESTIGATOR

• Mikael Truedsson

  Örestadskliniken Malmö

  PRINCIPAL INVESTIGATOR

• Elisabet Wieslander

  Division of Oncology and Pathology, Lund University

  PRINCIPAL INVESTIGATOR

• Thomas E Fehniger

  Clinical Protein Science & Imaging, Lund University

  PRINCIPAL INVESTIGATOR

• Magnus Dahlbäck

  Clinical Protein Science & Imaging, Lund University

  PRINCIPAL INVESTIGATOR

• Roger Appelqvist

  Clinical Protein Science & Imaging, Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Clincal Chemistry

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: February 1, 2014
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

SE (1)