Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT05932758
Status:
UNKNOWN
Last Update Posted:
2023-07-21
First Post:
2023-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Excisional Vacuum-Assisted Breast Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with complete removal of lesion', 'timeFrame': '6 months', 'description': 'Comparison of the percentage of patients with a lack of pathology (also in situ) at the surgery between the two groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atypical Ductal Hyperplasia', 'Ductal Carcinoma in Situ']}, 'referencesModule': {'references': [{'pmid': '39380737', 'type': 'DERIVED', 'citation': 'Nicosia L, Mariano L, Latronico A, Bozzini AC, Bellerba F, Gaeta A, Pesapane F, Mazzarol G, Fusco N, Corso G, Sangalli C, Gialain C, Lazzeroni M, Raimondi S, Cassano E. Exploring non-surgical alternatives for low to intermediate-grade in situ ductal carcinoma of the breast using vacuum-assisted excision: the VACIS protocol. Front Med (Lausanne). 2024 Sep 24;11:1467738. doi: 10.3389/fmed.2024.1467738. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS).', 'detailedDescription': 'Surgery is the current standard of care of breast lesions like the Ductal Carcinoma In Situ (DCIS) and the Atypical Ductal Hyperplasia (ADH). However, the survival benefit of surgical resection in patients with such lesions appears to be low, especially for ADH and low-grade DCIS where comorbidity of surgery and prior depression have been reported as important factors related to worse quality of life in these women.\n\nPatients with suspicious breast lesions (BIRADS\\>3) who are candidates for vacuum assisted breast biopsy will be prospectively select and enroll if the radiological lesion diameter is less than 15 mm.\n\nThe investigators will select those patients in whom after an initial sequence of sampling (12 cores), and will check the complete macroscopic removal of the lesion (with radiograms of the biopsied part of the breast). Those patients (complete macroscopic removal, with real-time verification during the procedure) will be randomized into two groups. A first group of patients will finish the biopsy procedure after the first collection sequence (12 cores, 3 grams of tissue taken and complete macroscopic removal). A second group of patients (randomized subdivision) will undergo a second sequence of biopsy samples (other 4 cores and 1 gram of tissue taken) in the same session: the material collected will be sent separately to the pathologist.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspicious breast lesions (BIRADS \\>3)\n* Patients with a lesion \\<= of 15mm.\n* Capable and willing to comply the specific informed consent form\n* Patients with ADH biopsy results or low intermediate-grade DCIS\n* Patients who will undergo surgery\n\nExclusion Criteria:\n\n\\- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study'}, 'identificationModule': {'nctId': 'NCT05932758', 'briefTitle': 'Excisional Vacuum-Assisted Breast Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Excisional Vacuum-Assisted Breast Biopsy (VAE): Application to Avoid Surgery in Atypical Ductal Hyperplasia and Low/Intermediate Grade Ductal Carcinoma in Situ of the Breast', 'orgStudyIdInfo': {'id': 'IEO 1856'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'no excisional biopsy', 'description': 'Patients in this arm underwent to an initial sequence of sampling (less than 4 g of tissue sampled)', 'interventionNames': ['Procedure: Not excisional biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'excisional biosy', 'description': 'Patients in this arm will undergo a second sequence of biopsy samples (at least 4g sampled)', 'interventionNames': ['Procedure: Vacuum-assisted excisional biopsy']}], 'interventions': [{'name': 'Vacuum-assisted excisional biopsy', 'type': 'PROCEDURE', 'description': 'at least 4g of tissue sampled (excisional biopsy)', 'armGroupLabels': ['excisional biosy']}, {'name': 'Not excisional biopsy', 'type': 'PROCEDURE', 'description': 'biopsy with less than 4 g of tissue sampled', 'armGroupLabels': ['no excisional biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Nicosia, MD', 'role': 'CONTACT'}], 'facility': 'Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Luca Nicosia, MD', 'role': 'CONTACT', 'email': 'luca.nicosia@ieo.it', 'phone': '+390294372449'}, {'name': 'Claudia Sangalli, MSc', 'role': 'CONTACT', 'email': 'claudia.sangalli@ieo.it'}], 'overallOfficials': [{'name': 'Luca Nicosia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministero della Salute, Italy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}