Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT07283718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Association Between Axillary Lymph Node Metastasis Patterns and Breast Cancer Prognosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2467}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': 'From the date of ALND until time of event up to 3 years', 'description': 'Disease-free survival time is defined as the time from the date of axillary lymph node dissection until the date of the first occurrence of local/regional relapse, distant recurrence, contralateral breast cancer, second malignancy and death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Recurrence-free survival', 'timeFrame': 'From the date of ALND until time of event up to 3 years', 'description': 'Recurrence-free survival time is defined as the time from the date of axillary lymph node dissection until the date of the first occurrence of local/regional recurrence, distant recurrence and death from any cause'}, {'measure': 'Overall survival', 'timeFrame': 'From the date of ALND until time of event up to 3 years', 'description': 'Overall survival time is defined as the time from the date of axillary lymph node dissection until death from any cause'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Invasive']}, 'descriptionModule': {'briefSummary': 'This is a real-world multicentre study to investigate the metastatic pattern of axillary lymph node and its association with breast cancer prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were pathologically diagnosed primary invasive breast cancer from October 2013 to December 2023. They had axillary lymph node dissection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Pathologically confirmed invasive primary breast cancer\n\nExclusion Criteria:\n\n* De novo stage IV breast cancer'}, 'identificationModule': {'nctId': 'NCT07283718', 'briefTitle': 'The Association Between Axillary Lymph Node Metastasis Patterns and Breast Cancer Prognosis', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'The Association Between Axillary Lymph Node Metastasis Patterns and Breast Cancer Prognosis：a Real-world Study', 'orgStudyIdInfo': {'id': 'LY2025-298-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALND', 'description': 'breast cancer patients receiving axillary lymph mode dissection', 'interventionNames': ['Procedure: ALND']}], 'interventions': [{'name': 'ALND', 'type': 'PROCEDURE', 'description': 'axillary lymph node dissection', 'armGroupLabels': ['ALND']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'country': 'China', 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Wenjin Yin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenjin Yin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief of Breast Surgery Department', 'investigatorFullName': 'Wenjin Yin', 'investigatorAffiliation': 'RenJi Hospital'}}}}