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Serum, Plasma, DNA and Tissue Bank in Chronic Obstructive Pulmonary Disease and Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00858520
Recruitment Status : Unknown
Verified September 2013 by Marc Decramer, KU Leuven.
Recruitment status was:  Recruiting
First Posted : March 10, 2009
Last Update Posted : September 4, 2013
Information provided by (Responsible Party):
Marc Decramer, KU Leuven

Brief Summary:

A biobank of Serum, plasma, DNA samples together with clinical information including specific questionnaires, complete pulmonary function and chest CT-scan, is prospectively collected in patients seen at the investigators' clinical service.

The objective is to study candidate gene pathways in COPD and or lung cancer and to associate them with the clinical characteristics and phenotypes of COPD/emphysema and lung cancer.

In subgroups of well characterised patients, other biological materials are also collected (lung tissue biopsies, peripheral blood mononuclear cells).

Condition or disease
Chronic Obstructive Pulmonary Disease Lung Cancer

Detailed Description:

All patients with a smoking history of at least 15 pack years, an minimal age of 50 years and an recent available CT scan are enrolled.

All subjects with a diagnosis of lung cancer are also collected (irrespective of age and smoking behavior).

In addition the investigators collect:

  • specific questionnaires (MRC, CCQ and smoking history)
  • medical and professional history
  • complete pulmonary function (spirometry, bodyplethysmography and diffusing capacity)
  • serum, plasma and DNA samples.

In specific subgroups the investigators also collect:

  • Peripheral blood mononuclear cells
  • Lung tissue - if available - from a surgical procedure (lung transplantation or lobectomy)

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Serum, Plasma, DNA and Tissue Bank of Patients With Chronic Obstructive Pulmonary Disease, Lung Cancer and Smoking Controls.
Study Start Date : October 2007
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Smoking controls
Smokers without lung cancer and without COPD
COPD patients
Smokers with COPD but without lung cancer
Lung cancer patients
smokers - never smokers with lung cancer

Primary Outcome Measures :
  1. Serological, cytological, histological and genetic analysis of biomarkers or genes which are involved in the pathogenesis of COPD/Emphysema/Lungcancer. [ Time Frame: 0-1-3-6 years ]
    All cases are prospectively collected in University hospital Leuven, Belgium. Of enrolled subjects data are collected at 0,1,3 and 6 years interval

Biospecimen Retention:   Samples With DNA
Germline DNA, serum and plasma, Peripheral blood mononuclear cells, Lung tissue biopsies

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Chronic Obstructive Pulmonary Disease and smoking controls.

Inclusion Criteria for smokers:

  • A smoking history of at least 15 pack years and age of 50 years or older
  • Complete pulmonary function on day of visit
  • Chest CT-scan within one year of enrollment
  • 4 weeks from exacerbation

Exclusion Criteria for smokers:

  • Less than 15 pack years
  • Younger than 50 year
  • Other pulmonary diseases interfering with CT or pulmonary function
  • Asthma

Inclusion Criteria for lung cancer patients:

  • new diagnosis of proven lung cancer
  • chest CT scan within 2 months of enrollment
  • Complete pulmonary function

Exclusion Criteria for lung cancer patients

  • not able to perform pulmonary function
  • Absence of histological diagnosis of lung cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00858520

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Contact: Wim Janssens, MD. PhD. 032 (16) 34 68 00
Contact: Kristien Debent 032 (16) 34 31 26

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Katholieke Universiteit Leuven Recruiting
Leuven, Flanders, Belgium, 3000
Contact: Wim Janssens, Prof    032 (16) 34 68 00   
Principal Investigator: Wim Janssens, MD. PhD.         
Sub-Investigator: Marc Decramer, MD. PhD.         
Sub-Investigator: Diether Lambrechts, PhD         
Sub-Investigator: Johan Vansteenkiste, MD, PhD         
Sub-Investigator: Paul Deleyn, MD PhD         
Sponsors and Collaborators
KU Leuven
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Principal Investigator: Wim Janssens, MD. PhD. KU Leuven
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Responsible Party: Marc Decramer, Prof.Dr., KU Leuven Identifier: NCT00858520    
Other Study ID Numbers: B32220072389
First Posted: March 10, 2009    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013
Keywords provided by Marc Decramer, KU Leuven:
Lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Respiratory Tract Diseases