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

September 2, 2013 updated by: Marc Decramer, KU Leuven

Serum, Plasma, DNA and Tissue Bank of Patients With Chronic Obstructive Pulmonary Disease, Lung Cancer and Smoking Controls.

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).

Study Overview

Status

Unknown

Conditions

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)

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Flanders
      • Leuven, Flanders, Belgium, 3000
        • Recruiting
        • Katholieke Universiteit Leuven
        • Contact:
        • Sub-Investigator:
          • Marc Decramer, MD. PhD.
        • Sub-Investigator:
          • Diether Lambrechts, PhD
        • Sub-Investigator:
          • Paul Deleyn, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Chronic Obstructive Pulmonary Disease and smoking controls.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-1-3-6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Wim Janssens, MD. PhD., KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 10, 2009

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 2, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B32220072389
  • S50623

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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