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

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ClinicalTrials.gov Identifier: NCT00858520
Recruitment Status : Recruiting
First Posted : March 10, 2009
Last Update Posted : September 4, 2013
Sponsor:
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


Group/Cohort
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


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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00858520


Contacts
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Contact: Wim Janssens, MD. PhD. 032 (16) 34 68 00 wim.janssens@uz.kuleuven.ac.be
Contact: Kristien Debent 032 (16) 34 31 26 kristien.debent@uz.kuleuven.ac.be

Locations
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Belgium
Katholieke Universiteit Leuven Recruiting
Leuven, Flanders, Belgium, 3000
Contact: Wim Janssens, Prof    032 (16) 34 68 00    wim.janssens@uz.kuleuven.ac.be   
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
Investigators
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Principal Investigator: Wim Janssens, MD. PhD. KU Leuven

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Responsible Party: Marc Decramer, Prof.Dr., KU Leuven
ClinicalTrials.gov Identifier: NCT00858520     History of Changes
Other Study ID Numbers: B32220072389
S50623
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:
COPD
Lung cancer
genes
DNA

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
Neoplasms
Respiratory Tract Diseases