Serum, Plasma, DNA and Tissue Bank in Chronic Obstructive Pulmonary Disease and Lung Cancer
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| First Received Date ICMJE | March 9, 2009 | ||||||||
| Last Updated Date | August 1, 2012 | ||||||||
| Start Date ICMJE | October 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] All cases are prospectively collected in University hospital Leuven, Belgium. Of enrolled subjects data are collected at 0,1,3 and 6 years interval |
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| Original Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Change History | Complete list of historical versions of study NCT00858520 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Serum, Plasma, DNA and Tissue Bank in Chronic Obstructive Pulmonary Disease and Lung Cancer | ||||||||
| Official Title ICMJE | Serum, Plasma, DNA and Tissue Bank of Patients With Chronic Obstructive Pulmonary Disease, Lung Cancer and Smoking Controls. | ||||||||
| 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). |
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| 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:
In specific subgroups the investigators also collect:
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Germline DNA, serum and plasma, Peripheral blood mononuclear cells, Lung tissue biopsies |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients with Chronic Obstructive Pulmonary Disease and smoking controls. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 2000 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria for smokers:
Exclusion Criteria for smokers:
Inclusion Criteria for lung cancer patients:
Exclusion Criteria for lung cancer patients
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| Gender | Both | ||||||||
| Ages | 25 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Belgium | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00858520 | ||||||||
| Other Study ID Numbers ICMJE | B32220072389, S50623 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Marc Decramer, Katholieke Universiteit Leuven | ||||||||
| Study Sponsor ICMJE | Katholieke Universiteit Leuven | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Katholieke Universiteit Leuven | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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