Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-29 @ 1:20 PM
Study NCT ID:
NCT06676761
Status:
RECRUITING
Last Update Posted:
2024-11-06
First Post:
2024-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of a Novel Technique Minimal Scar 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015414', 'term': 'Mastectomy, Subcutaneous'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}], 'ancestors': [{'id': 'D008408', 'term': 'Mastectomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oncological outcome', 'timeFrame': '5 years from operation', 'description': 'recurrence rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'nipple sparing mastectomy'], 'conditions': ['Breast Cancer Early Stage Breast Cancer (Stage 1-3)']}, 'referencesModule': {'references': [{'pmid': '28861374', 'type': 'BACKGROUND', 'citation': 'Lim GH, Allen JC, Ng RP. Oncoplastic round block technique has comparable operative parameters as standard wide local excision: a matched case-control study. Gland Surg. 2017 Aug;6(4):343-349. doi: 10.21037/gs.2017.03.06.'}, {'pmid': '30384398', 'type': 'BACKGROUND', 'citation': 'Lim GH. How to do minimal scar mastectomy: first-reported novel concept of nipple sparing mastectomy without reconstruction. ANZ J Surg. 2018 Dec;88(12):1345-1346. doi: 10.1111/ans.14941. Epub 2018 Nov 1. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Nipple sparing mastectomy is oncologically safe and has a good cosmetic outcome. However, nipple sparing mastectomy was conventionally performed with reconstruction. Minimal scar mastectomy (MSM) is a novel technique which could allow women, with non-ptotic breasts, who do not want reconstruction, to conserve their nipple areolar complex (NAC) and avoid the transverse scar associated with modified radical mastectomy. This is the first study on the oncologic and surgical outcomes of MSM.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'breast cancer patients with non-ptotic breasts, who do not want reconstruction, to conserve their nipple areolar complex (NAC) and avoid the transverse scar associated with modified radical mastectomy.', 'genderDescription': 'female breast cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: breast cancer patients who opted for minimal scar mastectomy -\n\nExclusion Criteria: breast cancer patients who underwent conventional mastectomy\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06676761', 'briefTitle': 'Outcomes of a Novel Technique Minimal Scar Mastectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'Outcomes of a Novel Technique Minimal Scar Mastectomy', 'orgStudyIdInfo': {'id': 'IRB 2020/2147'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'nipple sparing mastectomy without reconstruction', 'description': 'nipple sparing mastectomy without reconstruction', 'interventionNames': ['Procedure: nipple sparing mastectomy without reconstruction']}], 'interventions': [{'name': 'nipple sparing mastectomy without reconstruction', 'type': 'PROCEDURE', 'description': 'nipple sparing mastectomy was conventionally performed with reconstruction. we aim to study the outcomes in the group of patients with Minimal scar mastectomy (MSM) who have nipple sparing mastectomy without reconstruction', 'armGroupLabels': ['nipple sparing mastectomy without reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '238255', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Geok hoon Lim', 'role': 'CONTACT', 'email': 'ghlimsg@yahoo.com.sg', 'phone': '96392353'}], 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Geok hoon Lim', 'role': 'CONTACT', 'email': 'ghlimsg@yahoo.com.sg', 'phone': '96392353'}], 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Geok hoon Lim', 'role': 'CONTACT', 'email': 'ghlimsg@yahoo.com.sg', 'phone': '96392353'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'will consider sharing IPD when paper was accepted for publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}