Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-02-02 @ 4:09 PM
Study NCT ID:
NCT03737266
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2018-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Conventional With Sonography Assisted Breast Surgery After Neoadjuvant Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'R0 resection rate', 'timeFrame': '3 years', 'description': 'proportion of surgical procedures for cancer in which the surgeon is able to completely remove all detectable tumor tissue with negative margins, indicating that no cancer cells remain in the surgical site'}], 'secondaryOutcomes': [{'measure': 'Weight of primary resedate', 'timeFrame': '3 years', 'description': 'weight of the tumor tissue removed during surgery for cancer'}, {'measure': 'Time for cut and sew', 'timeFrame': 'During surgery', 'description': 'duration of the surgical procedure from the initial incision to the completion of the closure of the incision site'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Surgery']}, 'descriptionModule': {'briefSummary': 'Aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces the resection rate in the case of R1 resection compared to the procedure without sonographic visualisation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 to 80 years\n* Female\n* Presurgical validated breast cancer\n* Unifocal to multifocal findings\n* Palpable and/o non-palpable findings\n* Neoadjuvant chemotherapy\n* Indication for breast conserving therapy\n* General operation ability and anesthesia ability\n* Consent to conventional breast conserving breast surgery with wire marking\n* Ability and will to follow the study conditions\n* Written declaration of consent after clarification\n\nExclusion Criteria:\n\n* Sonographically not clearly delineate resection areal\n* Exclusion criteria for breast conserving therapy\n* Simultaneous participation in other interventional trials that interfere with this study at the investigator's discretion"}, 'identificationModule': {'nctId': 'NCT03737266', 'briefTitle': 'Comparison of Conventional With Sonography Assisted Breast Surgery After Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Sonographically Assisted Versus Conventionally Breast Surgery in Breast Cancer Patients With an Indication for Breast Conserving Surgery After Neoadjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'Seno_Ex_MAC 003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sonographically assisted breast surgery', 'description': 'Sonography assisted breast surgery', 'interventionNames': ['Procedure: Sonographically assisted breast surgery', 'Procedure: Conventional breast surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional breast surgery', 'description': 'Conventional breast surgery', 'interventionNames': ['Procedure: Sonographically assisted breast surgery', 'Procedure: Conventional breast surgery']}], 'interventions': [{'name': 'Sonographically assisted breast surgery', 'type': 'PROCEDURE', 'description': 'Sonography', 'armGroupLabels': ['Conventional breast surgery', 'Sonographically assisted breast surgery']}, {'name': 'Conventional breast surgery', 'type': 'PROCEDURE', 'description': 'Conventional', 'armGroupLabels': ['Conventional breast surgery', 'Sonographically assisted breast surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72086', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': "Department for Women's Health", 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Markus Hahn, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Women's Health, University Hospital Tuebingen"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}