Serum, Plasma and DNA Bank in Chronic Obstructive Pulmonary Disease

This study is currently recruiting participants.

Verified by Katholieke Universiteit Leuven, March 2009

First Received: March 9, 2009 No Changes Posted

Sponsors and Collaborators:	Katholieke Universiteit Leuven VIB
Information provided by:	Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00858520

Purpose

A Plasma, serum and DNA bank together with clinical information including specific questionnaires, complete pulmonary function and chest CT-scan, is prospectivelly collected in patients seen at the investigators' clinical service. The objective is to study candidate gene pathways in COPD and to associate them with the presence and severity of COPD/emphysema.

Condition
Chronic Obstructive Pulmonary Disease

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Serum, Plasma and DNA Bank of Patients With Chronic Obstructive Pulmonary Disease and Smoking Controls.

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:

Serological and genetic analysis of biomarkers or genes which are involved in the pathogenesis of COPD. [ Time Frame: 1-2-3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Germline DNA, serum and plasma

Estimated Enrollment:	1000
Study Start Date:	October 2007

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.

In addition we 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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Patients with Chronic Obstructive Pulmonary Disease and smoking controls.

Criteria

Inclusion Criteria:

A smoking history of at least 15 pack years
50 years or older
Complete pulmonary function on day of visit
Chest CT-scan within one year of enrollement
At least four weeks from exacerbation

Exclusion Criteria:

Less than 15 pack years
Younger than 50 year
Other pulmonary diseases interfering with CT or pulmonary function
Asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858520

Contacts

Contact: Wim Janssens, MD. PhD.	032 (16) 34 68 00	wim.janssens@uz.kuleuven.ac.be
Contact: Claudia Carremans	032 (16) 34 31 30	claudia.carremans@uz.kuleuven.ac.be

Locations

Belgium, Flanders
Katholieke Universiteit Leuven	Recruiting
Leuven, Flanders, Belgium, 3000
Contact: Wim Janssens, Prof 032 (16) 34 68 00 wim.janssens@uz.kuleuven.ac.be
Principal Investigator: Wim Janssens, MD. PhD.
Sub-Investigator: Marc Decramer, MD. PhD.
Sub-Investigator: Diether Lambrechts, PhD

Sponsors and Collaborators

Katholieke Universiteit Leuven

VIB

Investigators

Principal Investigator:	Wim Janssens, MD. PhD.	Katholieke Universiteit Leuven
Principal Investigator:	Wim Janssens, MD. PhD.	Katholieke Universiteit Leuven

More Information

No publications provided

Responsible Party:	Katholieke Universiteit Leuven ( Wim Janssens MD. PhD. )
Study ID Numbers:	B32220072389, S50623
Study First Received:	March 9, 2009
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00858520 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:

COPD
gene banking
DNA

Study placed in the following topic categories:

Smoking
Lung Diseases, Obstructive
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 06, 2009