CClinicalTrials.gg
Status unknownNCT00858520Updated Sep 4, 2013

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

An observational study in Chronic Obstructive Pulmonary Disease and Lung Cancer, sponsored by KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-04.

Sponsored by KU Leuven · Observational

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,000
Ages
25 Years and older
Sex
All
01

Study 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).

Read the 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)
02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Lung Cancer

Keywords

  • COPD
  • Lung cancer
  • genes
  • DNA
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with Chronic Obstructive Pulmonary Disease and smoking controls.

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Serological, cytological, histological and genetic analysis of biomarkers or genes which are involved in the pathogenesis of COPD/Emphysema/Lungcancer.

    All cases are prospectively collected in University hospital Leuven, Belgium. Of enrolled subjects data are collected at 0,1,3 and 6 years interval

    Time frame: 0-1-3-6 years

07

Study locations

1 of 1 sites recruiting
  • Katholieke Universiteit Leuven
    Leuven, Flanders 3000, Belgium
    • Wim Janssens, Prof · Contact · wim.janssens@uz.kuleuven.ac.be · 032 (16) 34 68 00
    • Wim Janssens, MD. PhD. · Principal investigator
    • Marc Decramer, MD. PhD. · Sub investigator
    • Diether Lambrechts, PhD · Sub investigator
    • Johan Vansteenkiste, MD, PhD · Sub investigator
    • Paul Deleyn, MD PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00858520
Lead sponsor
KU Leuven
Responsible party
Marc Decramer (Prof.Dr., KU Leuven) — Principal investigator
First posted
Mar 10, 2009
Start date
Oct 2007
Primary completion
Dec 2018 (estimated)
Completion
Dec 2019 (estimated)
Last update
Sep 4, 2013

Study contacts

Wim Janssens, MD. PhD.
Contact
wim.janssens@uz.kuleuven.ac.be
032 (16) 34 68 00
Kristien Debent
Contact
kristien.debent@uz.kuleuven.ac.be
032 (16) 34 31 26
Wim Janssens, MD. PhD.
principal investigator · KU Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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