Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT03421093
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2017-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Clinical Characteristics of Lung Cancer in Patients With Surgeries and Adjuvant Therapies
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21777}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2017-12-29', 'studyFirstSubmitQcDate': '2018-02-01', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Differences in overall survivals of the patients with surgeries', 'timeFrame': '2014 - 2017', 'description': 'Differences in perioperative overall survivals and overall survivals of the patients who received surgeries of thoracotomy, video-assistant thoracic surgery or robotic thoracic surgery'}, {'measure': 'Impact factors of patient survival in patients with tumor size =<2 cm who received surgeries as measured by tumor clinical/pathological staging', 'timeFrame': '2014 - 2017', 'description': 'Impact factors of patient survival in patients with tumor size =\\<2 cm who received surgeries as measured by tumor clinical/pathological staging'}, {'measure': 'Impact factors of patient survival in patients with tumor size =<2 cm who received surgeries as measured by location of tumors and tumor sizes', 'timeFrame': '2014 - 2017', 'description': 'Impact factors of patient survival in patients with tumor size =\\<2 cm who received surgeries as measured by location of tumors and tumor sizes'}, {'measure': 'Impact factors of patient survival in patients with tumor size =<2 cm who received surgeries as measured by duration and modes of surgeries', 'timeFrame': '2014 - 2017', 'description': 'Impact factors of patient survival in patients with tumor size =\\<2 cm who received surgeries as measured by duration and modes of surgeries'}, {'measure': 'Impact factors of patient survival in patients with tumor size =<2 cm who received surgeries as measured by type of insurances', 'timeFrame': '2014 - 2017', 'description': 'Impact factors of patient survival in patients with tumor size =\\<2 cm who received surgeries as measured by type of insurances'}, {'measure': 'Overall survival in the patients with tumor size =< 2cm who received surgeries', 'timeFrame': '2014 - 2017', 'description': 'Overall survival in the patients with tumor size =\\< 2cm who received surgeries'}, {'measure': 'Impact factors of patient survivals in the patients with N2 lung cancer with surgeries or surgeries plus adjuvant therapies', 'timeFrame': '2014 - 2017', 'description': 'Impact factors of patient survivals in the patients with N2 lung cancer who received surgeries or surgeries plus adjuvant therapies'}, {'measure': 'Overall survival in the patients with N2 lung cancer with surgeries or surgeries plus adjuvant therapies', 'timeFrame': '2014 - 2017', 'description': 'Overall survival in the patients with N2 lung cancer who received surgeries or surgeries plus adjuvant therapies'}, {'measure': 'Impact factors of patient survivals in the patients with small lung cancer with surgeries or surgeries plus adjuvant therapies', 'timeFrame': '2014 - 2017', 'description': 'Impact factors of patient survivals in the patients with small lung cancer who received surgeries or surgeries plus adjuvant therapies'}, {'measure': 'Overall survival in the patients with small lung cancer with surgeries or surgeries plus adjuvant therapies', 'timeFrame': '2014 - 2017', 'description': 'Overall survival in the patients with small lung cancer who received surgeries or surgeries plus adjuvant therapies'}, {'measure': 'Demographic characteristics of the patients with non-small cell lung cancer who were treated with chemotherapies, tyrosine kinase inhibitors, and other adjuvant therapies or were not treated with adjuvant therapies', 'timeFrame': '2014 - 2017', 'description': 'Demographic characteristics of the patients with non-small cell lung cancer who were treated with chemotherapies, tyrosine kinase inhibitors, and other adjuvant therapies or were not treated with adjuvant therapies as measured by:\n\n* Age\n* Gender\n* Payment types\n* Insurance types\n* Smoking history\n* Complications and symptoms of complications\n* Respiratory functions\n* Type of diagnoses'}, {'measure': 'Tumor clinical/pathological types', 'timeFrame': '2014 - 2017', 'description': 'Tumor clinical/pathological types'}, {'measure': 'Type of EGFR', 'timeFrame': '2014 - 2017', 'description': 'Type of EGFR'}, {'measure': 'ECOG scores', 'timeFrame': '2014 - 2017', 'description': 'ECOG scores'}, {'measure': '1-year and 3-year overall survivals', 'timeFrame': '2014 - 2017', 'description': '1-year and 3-year overall survivals'}], 'primaryOutcomes': [{'measure': 'Demographic characteristics of the patients with lung malignant tumors who received surgeries', 'timeFrame': '2014 - 2017', 'description': 'Demographic characteristics of the patients with lung malignant tumors who received surgeries of thoracotomy, video-assistant thoracic surgery or robotic thoracic surgery as measured by:\n\n* Age\n* Gender\n* Payment types\n* Insurance types\n* Smoking history\n* Complications and symptoms of complications\n* Respiratory functions\n* Type of diagnoses'}], 'secondaryOutcomes': [{'measure': 'Location of tumors and tumor sizes', 'timeFrame': '2014 - 2017', 'description': 'Location of tumors and tumor sizes'}, {'measure': 'Tumor clinical/pathological staging', 'timeFrame': '2014 - 2017', 'description': 'Tumor clinical/pathological staging'}, {'measure': 'Type of biomarkers', 'timeFrame': '2014 - 2017', 'description': 'Type of biomarkers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung cancer', 'Chinese', 'surgeries', 'adjuvant therapies'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The study was designed to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors', 'detailedDescription': 'The trial is a multi-centre real-world non-interventional observational study to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors via a retrospectively review method on the study data on patient demographic/tumor biological characteristics and clinical treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lung malignant tumors who were performed with surgeries', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years old;\n* Pathologically diagnosed lung malignant tumors after surgeries;\n* Patients with lung surgeries;\n* Patients with complete medical health records and follow-up visit information (at least one follow-up visit);\n\nExclusion Criteria:\n\n* Patients who were not performed with surgeries;\n* Pathologically diagnosed patients with benign diseases after surgeries;'}, 'identificationModule': {'nctId': 'NCT03421093', 'briefTitle': 'A Study to Evaluate Clinical Characteristics of Lung Cancer in Patients With Surgeries and Adjuvant Therapies', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'A Multi-centre Real-world Non-interventional Observational Study to Evaluate Clinical Characteristics of the Chinese Patients With Lung Malignant Tumors Who Received Surgeries or Surgeries Plus Adjuvant Therapies', 'orgStudyIdInfo': {'id': 'TSCI-4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgeries and adjuvant therapies', 'description': 'Surgeries or surgeries plus adjuvant therapies', 'interventionNames': ['Procedure: Surgeries']}], 'interventions': [{'name': 'Surgeries', 'type': 'PROCEDURE', 'otherNames': ['Adjuvant therapies'], 'description': 'Surgeries or surgeries plus adjuvant therapies', 'armGroupLabels': ['Surgeries and adjuvant therapies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan cancer hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital Affiliated to Huaxi Technology University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu cancer hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "Xi'an Tangdu Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300051', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Chest Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'First Hospital Affiliated to Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Lunxun Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'LinkDoc Technology (Beijing) Co. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lunxu Liu', 'investigatorAffiliation': 'West China Hospital'}}}}