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

NCT00858520 | Unknown

• 2 other identifiers: B32220072389S50623
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Obstructive Pulmonary Disease; Lung Cancer

Keywords

COPD; Lung cancer; genes; DNA

Outcome Measures

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

  0-1-3-6 years

Study Arms (3)

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

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Chronic Obstructive Pulmonary Disease and smoking controls.

You may qualify if:

• 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
• weeks from exacerbation

You may not qualify if:

• Less than 15 pack years
• Younger than 50 year
• Other pulmonary diseases interfering with CT or pulmonary function
• Asthma
• new diagnosis of proven lung cancer
• chest CT scan within 2 months of enrollment
• Complete pulmonary function
• not able to perform pulmonary function
• Absence of histological diagnosis of lung cancer

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, Flanders, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Germline DNA, serum and plasma, Peripheral blood mononuclear cells, Lung tissue biopsies

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Wim Janssens, MD. PhD.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wim Janssens, MD. PhD.

CONTACT

032 (16) 34 68 00; wim.janssens@uz.kuleuven.ac.be

Kristien Debent

CONTACT

032 (16) 34 31 26; kristien.debent@uz.kuleuven.ac.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: October 1, 2007
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

BE (1)