Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00858520
Status:
UNKNOWN
Last Update Posted:
2013-09-04
First Post:
2009-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serum, Plasma, DNA and Tissue Bank in Chronic Obstructive Pulmonary Disease and Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Germline DNA, serum and plasma, Peripheral blood mononuclear cells, Lung tissue biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-02', 'studyFirstSubmitDate': '2009-03-09', 'studyFirstSubmitQcDate': '2009-03-09', 'lastUpdatePostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serological, cytological, histological and genetic analysis of biomarkers or genes which are involved in the pathogenesis of COPD/Emphysema/Lungcancer.', 'timeFrame': '0-1-3-6 years', 'description': 'All cases are prospectively collected in University hospital Leuven, Belgium. Of enrolled subjects data are collected at 0,1,3 and 6 years interval'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Lung cancer', 'genes', 'DNA'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nIn subgroups of well characterised patients, other biological materials are also collected (lung tissue biopsies, peripheral blood mononuclear cells).", 'detailedDescription': '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.\n\nAll subjects with a diagnosis of lung cancer are also collected (irrespective of age and smoking behavior).\n\nIn addition the investigators collect:\n\n* specific questionnaires (MRC, CCQ and smoking history)\n* medical and professional history\n* complete pulmonary function (spirometry, bodyplethysmography and diffusing capacity)\n* serum, plasma and DNA samples.\n\nIn specific subgroups the investigators also collect:\n\n* Peripheral blood mononuclear cells\n* Lung tissue - if available - from a surgical procedure (lung transplantation or lobectomy)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Chronic Obstructive Pulmonary Disease and smoking controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for smokers:\n\n* A smoking history of at least 15 pack years and age of 50 years or older\n* Complete pulmonary function on day of visit\n* Chest CT-scan within one year of enrollment\n* 4 weeks from exacerbation\n\nExclusion Criteria for smokers:\n\n* Less than 15 pack years\n* Younger than 50 year\n* Other pulmonary diseases interfering with CT or pulmonary function\n* Asthma\n\nInclusion Criteria for lung cancer patients:\n\n* new diagnosis of proven lung cancer\n* chest CT scan within 2 months of enrollment\n* Complete pulmonary function\n\nExclusion Criteria for lung cancer patients\n\n* not able to perform pulmonary function\n* Absence of histological diagnosis of lung cancer'}, 'identificationModule': {'nctId': 'NCT00858520', 'briefTitle': 'Serum, Plasma, DNA and Tissue Bank in Chronic Obstructive Pulmonary Disease and Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Serum, Plasma, DNA and Tissue Bank of Patients With Chronic Obstructive Pulmonary Disease, Lung Cancer and Smoking Controls.', 'orgStudyIdInfo': {'id': 'B32220072389'}, 'secondaryIdInfos': [{'id': 'S50623'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smoking controls', 'description': 'Smokers without lung cancer and without COPD'}, {'label': 'COPD patients', 'description': 'Smokers with COPD but without lung cancer'}, {'label': 'Lung cancer patients', 'description': 'smokers - never smokers with lung cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Flanders', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Wim Janssens, Prof', 'role': 'CONTACT', 'email': 'wim.janssens@uz.kuleuven.ac.be', 'phone': '032 (16) 34 68 00'}, {'name': 'Wim Janssens, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marc Decramer, MD. PhD.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Diether Lambrechts, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Johan Vansteenkiste, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paul Deleyn, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Katholieke Universiteit Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Wim Janssens, MD. PhD.', 'role': 'CONTACT', 'email': 'wim.janssens@uz.kuleuven.ac.be', 'phone': '032 (16) 34 68 00'}, {'name': 'Kristien Debent', 'role': 'CONTACT', 'email': 'kristien.debent@uz.kuleuven.ac.be', 'phone': '032 (16) 34 31 26'}], 'overallOfficials': [{'name': 'Wim Janssens, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr.', 'investigatorFullName': 'Marc Decramer', 'investigatorAffiliation': 'KU Leuven'}}}}