Text Size

An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study (BIG3)

This study is not yet open for participant recruitment.
Verified August 2012 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01460264
First received: October 25, 2011
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

This is an observational study aiming to identify and validate biomarkers (including imaging and clinical descriptors) for chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD) and lung cancer.


Condition
Chronic Obstructive Pulmonary Disease
Cardiovascular Diseases
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: BIG3 - An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Region Skane:

Biospecimen Retention:   Samples With DNA

whole blood, serum


Estimated Enrollment: 10000
Study Start Date: October 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
exposed
current daily smokers 100 cigarettes or more during lifetime
unexposed
current non-smokers

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample,residents in Skåne county Sweden.

Criteria

Inclusion Criteria:

  • 45-75 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460264

Contacts
Contact: André Wennersten, PhD +46 46 17 53 65 andre.wennersten@skane.se
Contact: Ulf Malmqvist, MD, PhD +46 46 17 33 33 ulf.malmqvist@skane.se

Locations
Sweden
Skåne University Hospital
Lund, Sweden, 221 85
Sponsors and Collaborators
Region Skane
Investigators
Study Chair: Ulf Malmqvist, MD, PhD Skåne University Hospital
Principal Investigator: David Erlinge, MD, PhD Skåne University Hospital
Principal Investigator: Claes-Göran Löfdahl, MD, PhD Skåne University Hospital
Principal Investigator: Maria Planck Sturegård, MD, PhD Skåne University Hospital
  More Information

Publications:

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01460264     History of Changes
Other Study ID Numbers: BIG3-Region_Skane
Study First Received: October 25, 2011
Last Updated: August 9, 2012
Health Authority: Sweden: The National Board of Health and Welfare
Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Prospective Cohort Study
Respiratory Function Tests
Computed Tomography
Electrocardiography
Peripheral Arterial Disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Neoplasms
Lung Diseases, Obstructive
 Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013