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

August 23, 2022 updated by: Johan Malm, Lund University

Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) and Cardiovascular Diseases in Smokers/Ex-Smokers Attending Primary Care - Longitudinal Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden
        • Örestadskliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic in Malmö, Sweden

Description

Inclusion Criteria:

Diagnosed with COPD Gold stage 0-IV

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
GOLD stage I
GOLD Stage II
GOLD Stage III
GOLD Stage IV
Smokers/ex-smokers w/o COPD
non-Smokers w/o COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Advanced disease etiology requiring hospitalization.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Örestadskliniken

Investigators

  • Study Chair: Johan Malm, Clincal Chemistry, Lund University
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOL 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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