Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-28 @ 8:33 AM
Study NCT ID:
NCT04656769
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesia aNd caNcer recUrrence Lung cAncer Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 382}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-18', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cumulative incidence of recurrence and the overall survival', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recurrence tumor', 'Opioid use', 'Analgesia', 'thoracic surgery'], 'conditions': ['Recurrence Tumor', 'Opioid Use, Unspecified', 'Analgesia', 'Thoracic Surgery']}, 'descriptionModule': {'briefSummary': "The choice of analgesia after cancer surgery may play a role in the onset of recurrence, particularly opioids seem to play a role in the immune system by promoting cancer cell proliferation and migration. Based on this consideration, our aim was to assess the impact of perioperative analgesia's choice on cancer recurrence after curative surgery for Stage I Non-Small Cell Lung Cancer. The investigators retrospectively reviewed the records of patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012. Patients received analgesia either by peridural (PERI group) or, in case of patient refusal or failure in catheter positioning, intravenous analgesia with opioids (EV group). Follow-up was concluded in August 2019. The five-year cumulative incidence of recurrence and the overall survival were evaluated and adjusted with a propensity score matching methodology."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 yrs\n* Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012\n\nExclusion Criteria:\n\n* Age\\<18aa\n* Pregnancy\n* Day hospital patients'}, 'identificationModule': {'nctId': 'NCT04656769', 'briefTitle': 'Analgesia aNd caNcer recUrrence Lung cAncer Resection', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Impact of Analgesia on Cancer Recurrence and Mortality Within Five Years After Stage I Non-Small Cell Lung Cancer Resection', 'orgStudyIdInfo': {'id': 'ANNULAR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PERI group', 'interventionNames': ['Procedure: Peridural analgesia']}, {'label': 'EV group'}], 'interventions': [{'name': 'Peridural analgesia', 'type': 'PROCEDURE', 'description': 'We attempted to evaluate the effectiveness of peridural analgesia through cancer survival and recurrence outcomes.', 'armGroupLabels': ['PERI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10100', 'city': 'Torino', 'country': 'Italy', 'facility': 'AOU Città della Salute e della Scienza di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Luca Brazzi, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Torino'}, {'name': 'Giulio L Rosboch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U. Città della Salute e della Scienza'}, {'name': 'Ilaria De Domenici, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Torino'}, {'name': 'Edoardo Ceraolo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U. Città della Salute e della Scienza'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Luca Brazzi', 'investigatorAffiliation': 'University of Turin, Italy'}}}}