Chronic Obstructive Pulmonary DiseaseNCT00858520
Serum, Plasma, DNA and Tissue Bank in Chronic Obstructive Pulmonary Disease and Lung Cancer
An observational study of Chronic Obstructive Pulmonary Disease and Lung Cancer, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Lung Cancer
- How many people
- 2,000 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2007to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Chronic Obstructive Pulmonary Disease and smoking controls.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Katholieke Universiteit Leuven
Leuven, Flanders, 3000
Wim Janssens, Prof, 032 (16) 34 68 00, wim.janssens@uz.kuleuven.ac.be
Wim Janssens, MD. PhD.
About this study
Official title: 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).
Read the 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)
- Conditions
- Chronic Obstructive Pulmonary Disease, Lung Cancer
- Keywords
- COPD, Lung cancer, genes, DNA
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-1-3-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startOct 2007
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Decramer, KU Leuven
- Investigators
- Wim Janssens, MD. PhD., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858520
- Sponsor's protocol ID
- B32220072389
- Other IDs
- S50623
- Status last verified
- Sep 2013
- First submitted
- 9 Mar 2009
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum, Plasma, DNA and Tissue Bank of Patients With Chronic Obstructive Pulmonary Disease, Lung Cancer and Smoking Controls.
- ClinicalTrials.gov ID
- NCT00858520
- Acronym / sponsor ID
- B32220072389
- Conditions
- Chronic Obstructive Pulmonary Disease, Lung Cancer
- Keywords
- COPD, Lung cancer, genes, DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Obstructive Pulmonary Disease and smoking controls.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wim Janssens, MD. PhD. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Lung Cancer, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wim Janssens, MD. PhD. (032 (16) 34 68 00, wim.janssens@uz.kuleuven.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.