Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-01-01 @ 8:48 PM
Study NCT ID:
NCT06161935
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2023-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Lymph Node Metastatic Pattern Based Incorporating Tumor Location, GGO Components and Size for 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7067}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2023-11-30', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of participants with no mediastinal lymph metastases after systematic lymph node dissection.', 'timeFrame': '1 year', 'description': 'We counted the number of participants with no mediastinal lymph metastases after systematic lymph node dissection and tried to determine the situation of zero risk mediastinal lymph metastases after our analyses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer Non Small Cell']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about in invasive non-small cell lung cancer patients who underwent pulmonary resection with systematic lymph node dissection from April 2008 to July 2022 . The main question it aims to answer are: determine the situation of zero risk mediastinal lymph metastases and the different lymph node metastatic patterns of tumors with different characteristics.\n\nParticipants will provide personal information to analyze. and there is not a comparison group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '7067 invasive non-small cell lung cancer patients in FUSCC who underwent pulmonary resection with systematic lymph node dissection from April 2008 to July 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* invasive non-small cell lung cancer patients in FUSCC who underwent pulmonary resection with systematic lymph node dissection from April 2008 to July 2022\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06161935', 'briefTitle': 'A Study of Lymph Node Metastatic Pattern Based Incorporating Tumor Location, GGO Components and Size for Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Retrospective Study of Lymph Node Metastatic Pattern Based Incorporating Tumor Location, GGO Components and Size for Non-small Cell Lung Cancer Involving Patients in Thoracic Surgery Fudan University Shanghai Cancer Center From April 2008 to July 2022. Data Were Analyzed From October 2022 to July 2023 to Further Elaborated the Different Nodal Metastatic Pattern in Different Tumors and Identify the Characteristics of Patient Group Without Lymph Node Metastasis.', 'orgStudyIdInfo': {'id': 'JCY001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention, it is a retrospective study .'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Penghao Deng', 'investigatorAffiliation': 'Fudan University'}}}}