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BIG3: An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study

Sponsor
Region Skane (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT01460264
Collaborator
(none)
10,000
Enrollment
1
Location
157.5
Anticipated Duration (Months)
63.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    BIG3 - An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study
    Actual Study Start Date :
    Oct 16, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2026
    Anticipated Study Completion Date :
    Dec 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    exposed

    current daily smokers 100 cigarettes or more during lifetime
    unexposed

    current non-smokers

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      45 Years to 75 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • 45-75 years

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Skåne University Hospital Lund Sweden 221 85

      Sponsors and Collaborators

      • Region Skane

      Investigators

      • Study Chair: Ulf Malmqvist, MD, PhD, Skane University Hospital
      • Principal Investigator: David Erlinge, MD, PhD, Skane University Hospital
      • Principal Investigator: Claes-Göran Löfdahl, MD, PhD, Skane University Hospital
      • Principal Investigator: Maria Planck, MD, PhD, Skane University Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      Region Skane
      ClinicalTrials.gov Identifier:
      NCT01460264
      Other Study ID Numbers:
      • BIG3-Region_Skane
      First Posted:
      Oct 26, 2011
      Last Update Posted:
      Jan 13, 2022
      Last Verified:
      Jan 1, 2022
      Keywords provided by Region Skane
      Prospective Cohort Study
      Respiratory Function Tests
      Computed Tomography
      Electrocardiography
      Peripheral Arterial Disease
      Additional relevant MeSH terms:
      Lung Diseases, Obstructive
      Pulmonary Disease, Chronic Obstructive
      Cardiovascular Diseases

      Study Results

      No Results Posted as of Jan 13, 2022