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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00858520
• Other study ID #: B32220072389
• Secondary ID: S50623
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2009
• Last updated: September 2, 2013
• Start date: October 2007
• Est. completion date: December 2019

Study information

• Verified date: September 2013
• Source: Katholieke Universiteit Leuven
• Contact: Wim Janssens, MD. PhD.
• Phone: 032 (16) 34 68 00
• Email: wim.janssens[@]uz.kuleuven.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Cancer
• Lung Diseases
• Lung Diseases, Obstructive
• Lung Neoplasms
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Belgium	Katholieke Universiteit Leuven	Leuven	Flanders

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0-1-3-6 years	No