Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT05912569
Status:
RECRUITING
Last Update Posted:
2025-01-31
First Post:
2023-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success rate', 'timeFrame': '2 weeks later', 'description': 'The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['DCIS']}, 'descriptionModule': {'briefSummary': 'In the case of a patient undergoing total mastectomy for intraductal carcinoma (DCIS), the sentinel lymph node is not excised during the primary surgery but only marked for identification. If the final histological examination confirms invasive cancer, delayed surgery is performed to remove the sentinel lymph node that was marked during the initial surgery.\n\nprimary endpoint : The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.\n\naddendum) The previously documented Breast-Conserving Surgery has been corrected to reflect the accurate procedure of Total Mastectomy.', 'detailedDescription': "Primary surgery:\n\nPatients diagnosed with intraductal carcinoma through histological examination and scheduled for axillary lymph node dissection are included.\n\nPrior to the surgery, blue dye and/or radioisotope injection are used to identify the sentinel lymph node, similar to the current practice.\n\ntotal mastectomy surgery is performed. After identifying the sentinel lymph node in the axillary region, its location is marked using a titanium clip (size 2-4mm) or sutures (Maxon 3-0, a slow monofilament absorbable suture).\n\nThe number of marked sentinel lymph nodes is recorded for documentation.\n\nConfirmation of pathological examination results:\n\nIf the final surgical specimen confirms invasive carcinoma (size \\> 1mm) through pathological examination, sentinel lymph node surgery is performed.\n\naddendum)\n\n1. Suture Specification The surgical procedure will utilize Maxon 3-0, a slow monofilament absorbable suture for optimal tissue approximation and healing.\n2. Management of Microinvasive Cancer For cases where the tumor size is 1 mm or smaller (microinvasive cancer), the decision to proceed with reoperation will be made at the discretion of the treating physician based on clinical judgment.\n\nSecondary surgery:\n\nPrior to the surgery, an axillary view x-ray is taken to verify the location and number of the clips.\n\nBlue dye and/or radioisotope injection is administered near the axillary incision site.\n\nAccessing the axillary region involves identifying the marked areas using clips or sutures and detecting sentinel lymph nodes for biopsy.\n\nThe number of removed clips/sutures and the number of sentinel lymph nodes identified are documented for record keeping.\n\naddendum) Axillary X-ray and Sentinel Node Mapping Axillary x-ray and the use of blue dye or radioisotope injection for sentinel lymph node mapping are not mandatory and may be utilized at the physician's discretion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 20 to 75 years old.\n* Patients diagnosed with DCIS through histological examination.\n* Patients undergoing mastectomy\n\nExclusion Criteria:\n\n* In cases where the histopathological findings of the tissue examination indicate suspicious invasive lesions.\n* In cases where imaging tests or physical examinations suggest possible lymph node metastasis.\n* In patients who have previously undergone axillary lymph node surgery on the same side as the current procedure.\n* Pregnant patients.'}, 'identificationModule': {'nctId': 'NCT05912569', 'briefTitle': 'Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for DCIS', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ', 'orgStudyIdInfo': {'id': '2212-088-1386'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delay sentinel node biopsy', 'description': 'sinlge arm', 'interventionNames': ['Procedure: Delay sentinel node biopsy']}], 'interventions': [{'name': 'Delay sentinel node biopsy', 'type': 'PROCEDURE', 'description': 'In the case of a patient undergoing breast-conserving surgery for intraductal carcinoma, the sentinel lymph node is not excised during the primary surgery but only marked for identification. I', 'armGroupLabels': ['Delay sentinel node biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyeong-Gon Moon, MD', 'role': 'CONTACT', 'email': 'moonhgsurgi@gmail.com', 'phone': '02-2072-2634'}, {'name': 'Eunhye Kang, MD', 'role': 'CONTACT', 'email': 'rkd4327@naver.com', 'phone': '02-2072-2817'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyeong-Gon Moon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}