Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT04687956
Status:
RECRUITING
Last Update Posted:
2023-10-11
First Post:
2020-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Primary Surgical Prevention of Breast Cancer-related Lymphedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-09', 'studyFirstSubmitDate': '2020-11-29', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of lymphedema', 'timeFrame': '2 years after surgery', 'description': 'To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery.'}], 'secondaryOutcomes': [{'measure': 'UEL index', 'timeFrame': '2 years after surgery', 'description': 'To compare the UEL index'}, {'measure': 'Changes in Lymphoscintigraphy', 'timeFrame': '2 years after surgery', 'description': 'To compare the changes in lymphoscintigraphy presented by the change of transport index (TI)'}, {'measure': 'Incidence of lymphedema', 'timeFrame': '5 years after surgery', 'description': 'To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 5 years after the surgery.'}, {'measure': '5-year recurrence rate', 'timeFrame': '5 years after surgery', 'description': 'To compare the recurrence rate'}, {'measure': '5-year overall survival rate', 'timeFrame': '5 years after surgery', 'description': 'To compare the overall survival rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphedema', 'Mastectomy', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': "Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.", 'detailedDescription': 'Patients in the LYMPHA group undergo Axillary reverse mapping before the start of surgery, and after axillary lymph node resection, LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'Female patient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age over 19 years old\n2. Patients who are expected to undergo surgery under the diagnosis of breast cancer, and are determined to undergo axillary lymph node dissection before surgery.\n\nExclusion Criteria:\n\n1. Patients with vascular and lymph-related diseases\n2. Patients with a history of surgical treatment or trauma to both arms and axillary\n3. Patients with a history of receiving radiation treatment in both arms, chest, and axilla\n4. Patients with confirmed systemic metastasis with stage 4 breast cancer\n5. Pregnant and lactating patients'}, 'identificationModule': {'nctId': 'NCT04687956', 'acronym': 'LYMPHA', 'briefTitle': 'Primary Surgical Prevention of Breast Cancer-related Lymphedema', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema', 'orgStudyIdInfo': {'id': '3-2020-0343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LYMPHA', 'description': 'LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.', 'interventionNames': ['Procedure: LYMPHA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'No LYMPHA procedure is performed', 'interventionNames': ['Procedure: control']}], 'interventions': [{'name': 'LYMPHA', 'type': 'PROCEDURE', 'description': "Axillary reverse mapping is performed before surgery, axillary lymph node resection is performed, and 'LYMPHA' (Lymphatic microsurgical preventing healing approach) is performed, and the surgery is terminated. Subsequently, the occurrence of lymphedema is followed up.", 'armGroupLabels': ['LYMPHA']}, {'name': 'control', 'type': 'PROCEDURE', 'description': 'In the control group, axillary lymph node resection is performed and the surgery is terminated without additional procedures. Subsequently, the occurrence of lymphedema is followed up.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06273', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Soong June Bae, M.D.', 'role': 'CONTACT', 'email': 'mission815815@yuhs.ac', 'phone': '82-2-2019-4401'}], 'facility': 'Gangnam Severance Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Soong June Bae, M.D.', 'role': 'CONTACT', 'email': 'mission815815@yuhs.ac', 'phone': '82-2-2019-4401'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joon Jeong', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}