Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-03 @ 11:10 PM
Study NCT ID:
NCT05526456
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2022-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mapping of Lymph Node Metastasis and Survival For pN+ Superficial Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016629', 'term': 'Esophagectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2022-08-31', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LNM rates of the 207 thoracic T1N+ ESCC patients.', 'timeFrame': '2012.2-2022.4'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['National Cancer Center/Cancer Hospital']}, 'descriptionModule': {'briefSummary': 'With the deeper tumor invasion, the higher LNM rate beside the bilateral recurrent laryngeal nerves(RLN) was.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '73 Years', 'minimumAge': '44 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Among the 207 patients, 22 were in the T1a stage, whereas 185 were in the T1b stage. The invasion depth was EP in 2, LPM in 1, MM in 17, SM1 in 37, SM2 in 39 and SM3 in 97 patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Our predefined search strategy identified pT1N+ ESCC cases without preoperative treatment, between February 2012 and April 2022.\n\nExclusion Criteria:\n\n* The patients were excluded because they were (1)less than 10 lymph nodes removed; (2) lacked specific sites of LNM; or (3) incomplete follow-up information.'}, 'identificationModule': {'nctId': 'NCT05526456', 'briefTitle': 'Mapping of Lymph Node Metastasis and Survival For pN+ Superficial Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Center, China'}, 'officialTitle': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'orgStudyIdInfo': {'id': '20/388-2584'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Esophagectomy', 'type': 'PROCEDURE', 'description': 'McKeown, Ivor-Lewis, and Sweet procedure'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'investigatorFullName': 'Yin Li', 'investigatorAffiliation': 'National Cancer Center, China'}}}}