Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT06165094
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2023-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cervical Paraesophageal Lymph Node Metastasis Versus Supraclavicular Lymph Node Metastasis on the Overall Survival of Patients With Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2023-12-03', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2009.01.01-2017.12.30', 'description': 'OS was calculated from the month and year of surgery until the time of death or the last follow-up in March 2021.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oesophageal squamous cell carcinoma; cervical paraesophageal lymph node metastasis; supraclavicular lymph node metastasis; lymphadenectomy; esophagectomy'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about in health conditions of ESCC. The main question\\[s\\] it aims to answer are:\n\n•Lymph node metastasis(LNM) in cervical paraesophageal or supraclavicular which influence OS more.\n\nParticipants will describe the main status quo after surgery\n\nResearchers will compare Lymph node metastasis(LNM) in cervical paraesophageal and supraclavicular to see if dead.', 'detailedDescription': 'Demographic and pathologic data, including gender, age, pathological T stage, pathological N stage, 8th tumor-node-metastasis (TNM) stage, tumor location, tumor grade, lymphovascular invasion, perineural invasion, LNM, cervical paraesophageal LNM, supraclavicular LNM, and radical resection, were collected from the Sichuan Cancer Hospital and Institute Esophageal Cancer Case Management (SCH-ECCM) database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Demographic and pathologic data, including gender, age, pathological T stage, pathological N stage, 8th tumor-node-metastasis (TNM) stage, tumor location, tumor grade, lymphovascular invasion, perineural invasion, LNM, cervical paraesophageal LNM, supraclavicular LNM, and radical resection, were collected from the Sichuan Cancer Hospital and Institute Esophageal Cancer Case Management (SCH-ECCM) database.', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusion criteria were as follows:\n\n* patients who had undergone esophagectomy and\n* patients who exhibited LNM in the supraclavicular region.\n\nThe exclusion criteria:\n\n* tumor location outside the thoracic region,\n* pathological examination results confirming the presence of non-squamous cell carcinoma, - patients with both cervical paraesophageal LNM and supraclavicular LNM, or\n* those with missing required data'}, 'identificationModule': {'nctId': 'NCT06165094', 'acronym': 'ECPLNMvsSLNM', 'briefTitle': 'Effect of Cervical Paraesophageal Lymph Node Metastasis Versus Supraclavicular Lymph Node Metastasis on the Overall Survival of Patients With Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan Cancer Hospital and Research Institute'}, 'officialTitle': 'Effect of Cervical Paraesophageal Lymph Node Metastasis Versus Supraclavicular Lymph Node Metastasis on the Overall Survival of Patients With Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study', 'orgStudyIdInfo': {'id': 'SCCH-TS2206'}, 'secondaryIdInfos': [{'id': '2023YFQ0056', 'type': 'OTHER_GRANT', 'domain': 'Sichuan Key Research and Development Project from Science and Technology Department of Sichuan Province'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnosed with supraclavicular LNM', 'description': 'There was no intervention(s) in any group'}, {'label': 'Diagnosed with paraesophageal LNM', 'description': 'There was no intervention(s) in any group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Sichaun cancer hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Cancer Hospital and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yongtao Han', 'investigatorAffiliation': 'Sichuan Cancer Hospital and Research Institute'}}}}