Clinical trial NCT00858520: Serum, Plasma, DNA and Tissue Bank in Chronic Obstructive Pulmonary Disease and Lung Cancer
Official title: Serum, Plasma, DNA and Tissue Bank of Patients With Chronic Obstructive Pulmonary Disease, Lung Cancer and Smoking Controls.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lung Cancer
Keywords: COPD
Lung cancer
genes
DNA
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Chronic Obstructive Pulmonary Disease and smoking controls.

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).

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)

Eligibility 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

Primary outcomes:
measure: Serological, cytological, histological and genetic analysis of biomarkers or genes which are involved in the pathogenesis of COPD/Emphysema/Lungcancer.
timeFrame: 0-1-3-6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
state: Flanders
Study officials:
affiliation: KU Leuven
name: Wim Janssens, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: