Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-11 @ 5:48 AM
Study NCT ID:
NCT06511661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-25
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Significance of the Uncertain Resection in NSCLC
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3783}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-year disease-free survival', 'timeFrame': '5 years after surgery', 'description': 'The disease-free survival rate 5 years after surgery'}, {'measure': '5-year overall survival', 'timeFrame': '5 years after surgery', 'description': 'The overall survival rate 5 years after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer', 'Lymphadenectomy', 'R stage'], 'conditions': ['Non Small Cell Lung Cancer', 'Residual; State']}, 'descriptionModule': {'briefSummary': 'The concept of residual tumor classification proposed by the Union for International Cancer Control (UICC) was used to assess the completeness of surgical resection, and non-small cell lung cancer (NSCLC) patients with incomplete resection were more likely to occur recurrence, leading to significantly poor survival. But this R classification only refers to the surgical margin and neglects other factors associated with surgical quality, such as the extent of lymph node dissection (LND). Therefore, the International Association for the Study of Lung Cancer (IASLC) proposed the definition of uncertain resection \\[R(un)\\], which includes the suboptimal extent of LND. However, the clinical significance of R(un) is still controversial. On the one hand, some researches demonstrated that R(un) had definite prognostic significance, with R(un) survival stratifying between R0 and R1. On the other hand, some studies indicated that in early-stage NSCLC, the suboptimal extent of LND had no impact on survival, and the concept of R(un) might be insignificant in these patients. Even in those studies supporting the prognostic significance of R(un), which kind of patients is suitable for R(un) was still unclear. Thus, the investigators explore the impact of the R(un) on the long-term survival of patients with NSCLC using a large cohort in China, to identify those patients who could really benefit from the LND required by the R0 classification proposed by IASLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The data of included patients is extracted from the Hospital Information System of Sun Yat-sen University Cancer Center from 2001 to 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primary non-small cell lung cancer\n2. With pulmonary resection\n\nExclusion Criteria:\n\n1. Sublobar resection\n2. R1/R2\n3. Positive highest mediastinal lymph nodes\n4. Operative death'}, 'identificationModule': {'nctId': 'NCT06511661', 'briefTitle': 'Prognostic Significance of the Uncertain Resection in NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Prognostic Significance of the Uncertain Resection Based on the Extent of Nodal Dissection for Non-small Cell Lung Cancer: A Propensity Score Matching Retrospective Study', 'orgStudyIdInfo': {'id': 'B2024-401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'R0 group', 'description': 'Patients with NSCLC who underwent R0 surgery according to the R stage proposed by IASLC.', 'interventionNames': ['Procedure: Complete lymphadenectomy']}, {'label': 'R(un) group', 'description': 'Patients with NSCLC who underwent R(un) surgery according to the R stage proposed by IASLC.', 'interventionNames': ['Procedure: Incomplete lymphadenectomy']}], 'interventions': [{'name': 'Complete lymphadenectomy', 'type': 'PROCEDURE', 'description': 'At least 3 N1 stations and 3 N2 stations are examined during surgery, including station 7.', 'armGroupLabels': ['R0 group']}, {'name': 'Incomplete lymphadenectomy', 'type': 'PROCEDURE', 'description': 'Less than 3 N1 stations or 3 N2 stations are examined during surgery, or those without station 7 lymph node dissection.', 'armGroupLabels': ['R(un) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Mu-Zi Yang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mu-Zi Yang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}