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

C

Catholic University (KU) of Leuven

Status

Unknown

Conditions

Chronic Obstructive Pulmonary Disease
Lung Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT00858520
B32220072389
S50623

Details and patient eligibility

About

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).

Full 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)

Enrollment

2,000 estimated patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

2,000 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Kristien Debent; Wim Janssens, MD. PhD.

Data sourced from clinicaltrials.gov

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