Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-04 @ 10:14 PM
Study NCT ID:
NCT05917834
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2023-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-06-15', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loss of NAC sensory by pinprick test', 'timeFrame': '2-4 years after surgery', 'description': 'Difference in NAC sensory loss between the patients with two different incisions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NAC sensory', 'Mastectomy', 'NSM'], 'conditions': ['Breast Cancer', 'Nipple Sparing Mastectomy']}, 'descriptionModule': {'briefSummary': 'This study aims to assess nipple areolar complex sensation after nipple sparing mastectomy and compare the results according to different incisional approaches; specifically, inframammary fold (IMF) versus peri-areolar/radial. One-hundred-and-five post NSM patients from Oct 2019 to Nov 2021 have been recruited prospectively and evaluated for NAC sensory. A total of 97 patients (IMF 65 and peri-areolar/radial 32) were included in the analyses for comparison during follow up from 24 to 48 months after surgery. It was hypothesized that patients with IMF would have better outcomes for NAC senroy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with breast cancer undergoing nipple sparing mastectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Females who are older than 18\n2. Patients who underwent nipple sparing mastectomy in Gangnam Severance Hospital\n\nExclusion Criteria:\n\n1. Loss or excision of NAC due to post-surgical necrosis\n2. Diagnosis of other conditions that may interfere with cutaneous sensation'}, 'identificationModule': {'nctId': 'NCT05917834', 'briefTitle': 'Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy', 'orgStudyIdInfo': {'id': '3-2019-0235'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Imframammary', 'description': 'Imframammary- NSM using imframammary incision', 'interventionNames': ['Biological: Nipple sparing mastecomy with different incision placements']}, {'label': 'Radial/Peri-areolar', 'description': 'Radial/Peri-areolar- NSM using Radial/Peri-areolar incision', 'interventionNames': ['Biological: Nipple sparing mastecomy with different incision placements']}], 'interventions': [{'name': 'Nipple sparing mastecomy with different incision placements', 'type': 'BIOLOGICAL', 'description': 'Nipple sparing mastectomy was performed using Radial/Peri-areolar incision or imframammary incision', 'armGroupLabels': ['Imframammary', 'Radial/Peri-areolar']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'GangnamSeverance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joon Jeong', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}