Excisional Vacuum-Assisted Breast Biopsy
1 other identifier
interventional
300
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2023
CompletedFirst Submitted
Initial submission to the registry
June 27, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedJuly 21, 2023
July 1, 2023
2.3 years
June 27, 2023
July 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with complete removal of lesion
Comparison of the percentage of patients with a lack of pathology (also in situ) at the surgery between the two groups
6 months
Study Arms (2)
no excisional biopsy
OTHERPatients in this arm underwent to an initial sequence of sampling (less than 4 g of tissue sampled)
excisional biosy
EXPERIMENTALPatients in this arm will undergo a second sequence of biopsy samples (at least 4g sampled)
Interventions
at least 4g of tissue sampled (excisional biopsy)
Eligibility Criteria
You may qualify if:
- Patients with suspicious breast lesions (BIRADS \>3)
- Patients with a lesion \<= of 15mm.
- Capable and willing to comply the specific informed consent form
- Patients with ADH biopsy results or low intermediate-grade DCIS
- Patients who will undergo surgery
You may not qualify if:
- \- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- European Institute of Oncologylead
- Ministero della Salute, Italycollaborator
Study Sites (1)
Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS
Milan, 20141, Italy
Related Publications (1)
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.
PMID: 39380737DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Nicosia, MD
European Institute of Oncology IRCCS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2023
First Posted
July 6, 2023
Study Start
January 17, 2023
Primary Completion
April 30, 2025
Study Completion
July 31, 2025
Last Updated
July 21, 2023
Record last verified: 2023-07