Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT02502695
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2015-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-08', 'studyFirstSubmitDate': '2015-06-26', 'studyFirstSubmitQcDate': '2015-07-17', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Readmissions rates within 30 days of the patient's surgery date", 'timeFrame': '30 Days'}, {'measure': "Incidence of post-operative complications within 30 days of the patient's surgery date", 'timeFrame': '30 Days'}, {'measure': 'Total inpatient cost', 'timeFrame': '30 Days'}], 'secondaryOutcomes': [{'measure': 'Difference in readmission rates between the two cohorts', 'timeFrame': '3 years', 'description': 'To compare current VATS-associated procedures with a set of best VATS-associated practives implemented across the participating study centers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VATS Lobectomy and Segmentectomy for Lung Cancer', 'Lung Cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a research study for participants who have been diagnosed with lung cancer and are receiving VATS (Video Assisted Thoracoscopic Surgery) lobectomy or segmentectomy. The overall objective of this study is to develop a database to collect data on participants who are undergoing VATS lobectomy or segmentectomy for lung cancer.', 'detailedDescription': 'This database will be used as for quality improvement purposes. Furthermore, the database will help in collecting data in an organized fashion, which will help the investigators learn more about the details of the workup performed prior to the surgery, during the surgery, peri-operative management and early follow-up. The investigators hope that this database will help to determine a common guideline to perform VATS lobectomy or segmentectomy. By creating a common guideline for future treatment of VATS patients, the investigators predict the efficiency of the process will increase significantly without decreasing, and perhaps even improving, the quality of the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants that will have VATS lobectomy and segmentectomy procedures for lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects\n* Age ≥ 18 years\n* Underwent a VATS lobectomy or segmentectomy procedure for lung cancer -- Note: patients with other malignancies are eligible if they have a primary cancer of the lung as defined above\n\nExclusion Criteria:\n\n* Subjects undergoing thoracotomy lobectomy or segmentectomy for lung cancer\n* Subjects undergoing surgical procedures other than VATS lobectomy or segmentectomy for lung cancer'}, 'identificationModule': {'nctId': 'NCT02502695', 'briefTitle': 'A Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Prospective, Observational, Quality Improvement Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)', 'orgStudyIdInfo': {'id': '15-193'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1-VATS-associated best practices', 'description': '* Data to be collected will include demographic data and information about the pre-operative workup, surgical procedure, postoperative course and early discharge course for these patients.\n* After the last patient completes the 30-day post surgery follow-up, the investigators will determine a set of best practices to implement at each of the sites for the quality improvement initiative. During the assessment period, no patients will be enrolled into the study.', 'interventionNames': ['Other: VATS-associated best practices']}, {'label': 'Cohort 2-VATS-associated best practices', 'description': '-Once the set of VATS-associated best practices, an additional cohort of approximately 200 patients will be enrolled and followed in a manner identical to the first cohort.', 'interventionNames': ['Other: VATS-associated best practices']}], 'interventions': [{'name': 'VATS-associated best practices', 'type': 'OTHER', 'armGroupLabels': ['Cohort 1-VATS-associated best practices', 'Cohort 2-VATS-associated best practices']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': "Providence Saint John's Health Center", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Austell', 'state': 'Georgia', 'country': 'United States', 'facility': 'WellStar Medical Group', 'geoPoint': {'lat': 33.81261, 'lon': -84.63438}}, {'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'North Shore University Health System', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Scott J. Swanson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ethicon Endo-Surgery', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Scott J. Swanson, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}