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

NCT ID: NCT00858520

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2019-12-31

Brief Summary

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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).

Detailed Description

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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)

Conditions

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Chronic Obstructive Pulmonary Disease Lung Cancer

Keywords

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COPD Lung cancer genes DNA

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Smoking controls

Smokers without lung cancer and without COPD

No interventions assigned to this group

COPD patients

Smokers with COPD but without lung cancer

No interventions assigned to this group

Lung cancer patients

smokers - never smokers with lung cancer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


* new diagnosis of proven lung cancer
* chest CT scan within 2 months of enrollment
* Complete pulmonary function

Exclusion Criteria

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


* not able to perform pulmonary function
* Absence of histological diagnosis of lung cancer
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Marc Decramer

Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wim Janssens, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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Katholieke Universiteit Leuven

Leuven, Flanders, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Wim Janssens, MD. PhD.

Role: CONTACT

Phone: 032 (16) 34 68 00

Email: [email protected]

Kristien Debent

Role: CONTACT

Phone: 032 (16) 34 31 26

Email: [email protected]

Facility Contacts

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Wim Janssens, Prof

Role: primary

Other Identifiers

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S50623

Identifier Type: -

Identifier Source: secondary_id

B32220072389

Identifier Type: -

Identifier Source: org_study_id