Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-04-16 @ 8:43 PM
Study NCT ID:
NCT02923635
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2016-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-03', 'studyFirstSubmitDate': '2016-10-02', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Margins in all specimens measured in millimeters', 'timeFrame': 'Two years'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction assessed using questionnaire', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oncoplastic breast surgery', 'Standard Wide Local Excision'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and its impact on patient satisfaction.', 'detailedDescription': 'This non-randomized prospective trial was conducted on70 female patients presented to tertiary breast unit-Ain Shams University hospitals with breast cancer during the period from September 2012 to February 2013. All patients sharing in the study signed an informed consent that was approved in the ethical committee held on April 2012. Patients were classified in two groups each one 35 patients: group (A) standard wide local excision and group (B) oncoplastic group. Standard wide local excision done by general breast surgeons while oncoplastic surgeries done by breast surgeon assisted by plastic surgeon. The following data were recorded: Age, family history, margin length, weight and volume of the specimen, margin status and patient satisfaction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with macromastia in oncoplastic group.\n* Tumors \\>20% of breast volume in oncoplastic group.\n* Young patients in oncoplastic group\n* Tumors in medial or central quadrants in oncoplastic group\n\nExclusion Criteria:\n\n* Patients \\>60 years.\n* Patients with co-morbidities in oncoplastic group.\n* Tumors \\>20% of breast volume in standard group.\n* Tumors in medial or central quadrants in standard group'}, 'identificationModule': {'nctId': 'NCT02923635', 'briefTitle': 'A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision:Margin Length and Patient Satisfaction', 'orgStudyIdInfo': {'id': '006379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Wide Local Excision group', 'description': 'Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .', 'interventionNames': ['Procedure: Standard wide local excision.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oncoplastic group', 'description': 'Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures', 'interventionNames': ['Procedure: oncoplastic breast surgery.']}], 'interventions': [{'name': 'Standard wide local excision.', 'type': 'PROCEDURE', 'description': 'Excision of breast cancer without integration of plastic technique', 'armGroupLabels': ['Standard Wide Local Excision group']}, {'name': 'oncoplastic breast surgery.', 'type': 'PROCEDURE', 'description': 'Integration of plastic techniques with oncological surgery for resection of breast cancer.', 'armGroupLabels': ['Oncoplastic group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of General surgery', 'investigatorFullName': 'Yasser Mohamed Abdel-samii', 'investigatorAffiliation': 'Ain Shams University'}}}}