Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-04-11 @ 1:21 AM
Study NCT ID:
NCT00558350
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2007-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-14', 'studyFirstSubmitDate': '2007-11-13', 'studyFirstSubmitQcDate': '2007-11-13', 'lastUpdatePostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokine levels in blood, bronchial lavage fluid and pleural fluid', 'timeFrame': '2 years'}, {'measure': 'Correlation between cytokine levels and pulmonary morbidity', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Comparison of this collective with transthoracic esophagectomies and evaluation of the inflammatory reactions (esophageal collective registered:NCT00512265)', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lobectomy', 'inflammatory reaction', 'intrapulmonary', 'intrapleural'], 'conditions': ['Lung Neoplasms']}, 'descriptionModule': {'briefSummary': 'Inflammatory reaction in different compartments of the body may have a negative effect on outcome. This study assesses the inflammatory reaction systemically, intrapulmonary and intrapleural by measuring different cytokines. Patients with lung cancer undergoing lobectomy or segmentectomy are included in the study. Hypothesis: The inflammatory reaction in the pleural space is high compared to the systemic and intrapulmonary ones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all patients undergoing lobectomy or segmentectomy for lung cancer at a single institution', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective lobectomy\n* elective segmentectomy\n* 20-90 years\n* informed consent given\n\nExclusion Criteria:\n\n* emergency operations\n* pneumonectomy'}, 'identificationModule': {'nctId': 'NCT00558350', 'briefTitle': 'Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery', 'orgStudyIdInfo': {'id': '68/07'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'lobectomy / segmentectomy in patients with lung cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Urs Zingg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}