Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-27 @ 7:00 AM
Study NCT ID:
NCT06926335
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oncological Safety of Oncoplastic Breast Surgery in Multicentric 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': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer', 'timeFrame': '5 years', 'description': 'Number of multicentric breast cancer who underwent breast conservative surgery with no recurrance'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast conservative surgery'], 'conditions': ['Safety of Breast Coservative Multicenteric Breast Cancer', 'Breast Neoplasms', 'Breast Cancer', 'Multicentric']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer', 'detailedDescription': 'Breast cancer is the most prevalent cancer in women worldwide, accounting for about 23.8%. Multifocal and multicentric breast tumors are defined as two or more neoplasms separated in one breast. In multifocal tumors, a quarter of the breast is involved while in multicentric tumors, two quarters or more are involved. There is no exact radiological definition, but the distance between the multifocal tumors is less than or equal to 5 cm, whereas the distance between multicentric tumors is 5 cm, or more.\n\nDue to increasingly use of more developed imaging methods such as tomosynthesis, magnetic resonance imaging (MRI) in these patients, we face more MF/MC breast cancer cases. It is seen that MF/MC breast cancer incidence ranges from 6% to 75% in different series.\n\nBreast-conserving surgery (BCS) and radiotherapy have been adopted as the main treatment methods for early breast cancer. However, there are some studies stating that BCS carries risks for local recurrence in patients with MF/MC breast cancer.\n\nOncoplastic breast conservation (OBC) relies on applying plastic surgery principles within the context of sound oncological resection. Volume-reducing or volume- replacing methods are utilised to optimise postoperative appearances whilst prioritizing negative margin resection, supported by prompt adjuvant therapy. In fact, it is agreed that in cases where more than 20% of the breast tissue must be excised for oncological margin clearance, oncoplastic surgery is likely to require more complex techniques.This may allow larger specimens to be resected than in traditional breast conservation surgery, but with comparable histopathological properties to those who would be offered mastectomy.\n\nPrevious work has suggested that as such, OBC should be regarded as a separate entity from breast conservation therapy, and that direct comparison with mastectomy outcomes should be performed to inform decision-making amongst clinicians and with patients when planning for surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of multicentric breast cancer underwent oncoplastic breast surgery from 2020 to 2025', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with multicentric breast cancer\n* Female Patient aged from 18 to 65 years old\n* Patients who are fit for general anesthesia.\n* Patients who provide a written informed consent.\n* Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information\n\nExclusion Criteria:\n\n* Female patients less than 20 years old\n* Stage 4 breast cancer\n* Patients who are contraindicated for radiotherapy\n* Pregnant patients in first trimester\n* Patient with inflammatory carcinoma'}, 'identificationModule': {'nctId': 'NCT06926335', 'briefTitle': 'Oncological Safety of Oncoplastic Breast Surgery in Multicentric Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Oncological Safety of Oncoplastic Breast Surgery in Multicentric Breast Retrospective Study', 'orgStudyIdInfo': {'id': 'Breast conserve'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Breast consevative surgery', 'type': 'PROCEDURE', 'description': 'plastic surgery principles within the context of sound oncological resection. Volume-reducing or volume- replacing methods are utilised to optimise postoperative appearances whilst prioritizing negative margin resection, supported by prompt adjuvant therapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assuit University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgery Resident', 'investigatorFullName': 'Alshymaa Abd-Elhars Ebrahem', 'investigatorAffiliation': 'Assiut University'}}}}