Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-01 @ 10:44 PM
Study NCT ID:
NCT07069803
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2025-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oncologic Outcomes of Minimal Access Nipple-sparing Mastectomy Compared With Conventional Approach in Breast Cancer
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': 1129}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local recurrence', 'timeFrame': '10 years', 'description': 'local recurrence'}, {'measure': 'distant metastasis', 'timeFrame': '10 years', 'description': 'distant metastasis'}, {'measure': 'disease free survival', 'timeFrame': '10 years', 'description': 'disease free survival'}, {'measure': 'overall survival', 'timeFrame': '10 years', 'description': 'overall survival'}], 'secondaryOutcomes': [{'measure': 'operative duration', 'timeFrame': 'during surgery', 'description': 'operative duration'}, {'measure': 'intra-operative blood loss', 'timeFrame': 'during surgery', 'description': 'intra-operative blood loss'}, {'measure': 'post-operative complications', 'timeFrame': '30 days post-operatively', 'description': 'post-operative complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nipple-sparing mastectomy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'In this study the investigators investigate the oncological outcomes of minimal access nipple sparing mastectomy compared with conventional nipple sparing mastectomy for the treatment of breast cancer', 'detailedDescription': 'A retrospective analysis of a prospectively collected database was conducted from single institute to compare the oncologic outcomes of MA-NSM versus C-NSM. The clinical results and oncologic outcome (margin involved rate, local recurrence and overall survival) were compared between groups. To prevent bias, a case control approach was conducted with propensity score matching (PSM) method.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'NSM patients at CCH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary operable breast cancer and had undergone NSM\n\nExclusion Criteria:\n\n* had metastatic disease, non-malignant breast disease cases, bilateral breast cancer cases, recurrent breast cancer as well as male breast cancer cases and patients who did not undergo NSM'}, 'identificationModule': {'nctId': 'NCT07069803', 'briefTitle': 'Oncologic Outcomes of Minimal Access Nipple-sparing Mastectomy Compared With Conventional Approach in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Changhua Christian Hospital'}, 'officialTitle': 'Long-term Oncologic Outcomes of Minimal Access (Endoscopic or Robotic Assisted) Nipple-sparing Mastectomy Compared With Conventional Approach in Breast Cancer - a Propensity Score Matching Analysis', 'orgStudyIdInfo': {'id': 'CCH-IRB-231217'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'minimal acccess NSM', 'description': 'minimal acccess NSM'}, {'label': 'conventional NSM', 'description': 'conventional NSM'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jun Su, MBBS, FRCS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Changhua Christian Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}