Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 10:42 AM
Study NCT ID:
NCT05246592
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2022-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072656', 'term': 'Breast Cancer Lymphedema'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Risk model', 'timeFrame': '5 years', 'description': 'To establish a risk model of upper limb edema and dysfunction after axillary dissection for breast cancer'}], 'primaryOutcomes': [{'measure': 'short-term Incidence of lymphedema', 'timeFrame': '1-, 6-, and 12-month', 'description': 'Incidence of upper limb lymphedema on affected side at 1-, 6-, and 12-month after operation'}, {'measure': 'short-term Incidence of dysfunction', 'timeFrame': '1-, 6-, and 12-month', 'description': 'Incidence of upper limb dysfunction on affected side at 1-, 6-, and 12-month after operation'}], 'secondaryOutcomes': [{'measure': 'long-term Incidence of lymphedema', 'timeFrame': '5 years', 'description': 'Incidence of upper limb lymphedema on affected side 5 years after operation'}, {'measure': 'long-term Incidence of dysfunction', 'timeFrame': '5 years', 'description': 'Incidence of upper limb dysfunction on affected side 5 years after operation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Axillary Lymph Node Dissection', 'Post-mastectomy Lymphedema', 'Upper Limb Dysfunction', 'axillary lymphatic reflux', 'axillary vein reflux'], 'conditions': ['Breast Cancer Lymphedema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the difference in the incidence of upper limb edema and dysfunction between the Preponderant lymphatic reflux group (high ratio of axillary lymphatic reflux to axillary vein reflux) and the Preponderant venous reflux group (low ratio of axillary lymphatic reflux to axillary vein reflux).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients recruited in the PLEDGE study （NCT05120180）', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-69 years old,\n* Regardless of gender,\n* Breast masses were diagnosed by histology and pathology, stage II -III.\n* Clinical palpation of axillary lymph nodes is positive, or\n* Axillary lymph node puncture pathology is positive, or\n* The multidisciplinary treatment cooperation group (MDT) recommends axillary lymph node dissection,\n* Good physical state score (0-1),\n* No severe organ complications,\n* No congenital or acquired diseases affecting the normal morphology and functional activities of the upper limbs,\n* Informed consent, understanding and compliance with research requirements.\n\nExclusion Criteria:\n\n* Pregnancy or lactation,\n* Inflammatory breast cancer,\n* Clinical findings of metastatic lesions,\n* Sentinel lymph node biopsy was negative,\n* History of upper limb or shoulder, chest, back trauma or surgery,\n* Previous history of local radiotherapy,\n* History of other tumors,\n* Vascular embolic disease,\n* Those who are unable to comply with the clinical trial requirements for any reason.'}, 'identificationModule': {'nctId': 'NCT05246592', 'acronym': 'PLEDGE-R', 'briefTitle': 'Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"}, 'officialTitle': 'Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision Differs Due to the Ratio of Axillary Lymphatic and Axillary Vein Reflux in Breast Cancer Patients: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'JTU-6H-20211230001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preponderant lymphatic reflux group', 'description': 'high ratio of axillary lymphatic reflux to axillary vein reflux', 'interventionNames': ['Procedure: Branches Sparing', 'Procedure: None Branches Sparing']}, {'label': 'Preponderant venous reflux group', 'description': 'low ratio of axillary lymphatic reflux to axillary vein reflux', 'interventionNames': ['Procedure: Branches Sparing', 'Procedure: None Branches Sparing']}], 'interventions': [{'name': 'Branches Sparing', 'type': 'PROCEDURE', 'description': 'The patients will undergo axillary lymph node dissection with preserved axillary vein branches', 'armGroupLabels': ['Preponderant lymphatic reflux group', 'Preponderant venous reflux group']}, {'name': 'None Branches Sparing', 'type': 'PROCEDURE', 'description': 'The patients will undergo axillary lymph node dissection without preserved axillary vein branches', 'armGroupLabels': ['Preponderant lymphatic reflux group', 'Preponderant venous reflux group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200233', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '201499', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Fengxian Central Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'XIANGYUN ZONG, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangyun Zong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Breast Cancer, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Xiangyun Zong', 'investigatorAffiliation': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"}}}}