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
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|
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)
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Observational Model:||Case Control|
|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|
Smokers without lung cancer and without COPD
Smokers with COPD but without lung cancer
Lung cancer patients
smokers - never smokers with lung cancer
- 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
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
|Contact: Wim Janssens, MD. PhD.||032 (16) 34 68 firstname.lastname@example.org|
|Contact: Kristien Debent||032 (16) 34 31 email@example.com|
|Katholieke Universiteit Leuven||Recruiting|
|Leuven, Flanders, Belgium, 3000|
|Contact: Wim Janssens, Prof 032 (16) 34 68 00 firstname.lastname@example.org|
|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|
|Principal Investigator:||Wim Janssens, MD. PhD.||KU Leuven|