Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-28 @ 9:23 PM
Study NCT ID:
NCT03429192
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2018-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Explore Clinical Characteristics and Prognoses of N2 Patients With Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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': 2653}, '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': '2018-02-05', 'studyFirstSubmitQcDate': '2018-02-05', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difference in overall survival (OS) (in the subgroups of patients)', 'timeFrame': '2014 - 2017', 'description': 'OS difference in subgroups of patients with lymph skip metastases and non-skip metastases categorised by baseline characteristics'}, {'measure': 'Hazard factors of overall survival', 'timeFrame': '2014 - 2017', 'description': 'Hazard factors of overall survival'}], 'primaryOutcomes': [{'measure': 'Difference in overall survival (OS)', 'timeFrame': '2014 - 2017', 'description': 'OS difference in the subgroups of N2 patients with lymph skip metastases and non-skip metastases'}], 'secondaryOutcomes': [{'measure': 'Percentage of N2 patients with lymph skip metastases', 'timeFrame': '2014 - 2017', 'description': 'Percentage of N2 patients with lymph skip metastases'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chinese, real-world evidences, NSCLC, lymph skip metastases'], 'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '31902592', 'type': 'DERIVED', 'citation': 'Li X, Li X, Fu X, Liu L, Liu Y, Zhao H, Li Y, Hu J, Xu L, Liu D, Yang H, Zhang X. Survival benefit of skip metastases in surgically resected N2 non-small cell lung cancer: A multicenter observational study of a large cohort of the Chinese patients. Eur J Surg Oncol. 2020 Oct;46(10 Pt A):1874-1881. doi: 10.1016/j.ejso.2019.12.015. Epub 2019 Dec 18.'}]}, 'descriptionModule': {'briefSummary': 'A study to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases', 'detailedDescription': 'A multi-centre real-world non-interventional observational study to retrospectively collect the study data on patient demographic/tumor biological characteristics and clinical treatments to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pathologically diagnosed Chinese NSCLC patients with chest surgeries and lymphadenectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with surgeries from 2014 to 2017;\n* Pathologically diagnosed patients with non-small cell lung cancer;\n* Age \\> 18 years old;\n* Patients with chest surgeries before hospitalization;\n* Patients with N2 lymph nodes (+) after surgeries who received lymphadenectomy (Group 10 and 11 lymph nodes);\n\nExclusion Criteria:\n\n\\- Patients with radiotherapies, chemotherapies and biological therapies for tumors'}, 'identificationModule': {'nctId': 'NCT03429192', 'briefTitle': 'A Study to Explore Clinical Characteristics and Prognoses of N2 Patients With Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Chest Hospital'}, 'officialTitle': 'A Multi-centre Real-world Non-interventional Observational Study to Explore Clinical Characteristics of Lymph Skip Metastases and Prognoses of N2 Patients With Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'TJ-N2LC-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'N2 non-small cell lung cancer', 'description': 'Chinese patients with N2 non-small cell lung cancer', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Surgeries plus dissection of lymph nodes', 'armGroupLabels': ['N2 non-small cell lung cancer']}]}, '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 People's Liberation Army 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': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710000', 'city': "Xi'an", 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Xi'an Tangdu Hospital"}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Huaxi Hospital Affiliate to Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'First Hospital Affiliated to Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Xun Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Chest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Chest Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'LinkDoc Technology (Beijing) Co. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lingyu Huang', 'investigatorAffiliation': 'Tianjin Chest Hospital'}}}}