Clinical trial · Interventional
Excisional Vacuum-Assisted Breast Biopsy
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
NCT05932758CI-TRIAL-00068161unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Ductal Hyperplasia | Breast Atypical Ductal Hyperplasia | ALIAS | 0.90 |
| Ductal Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Not excisional biopsy | Procedure | — | UNRESOLVED |
| Vacuum-assisted excisional biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
- measure
- Percentage of patients with complete removal of lesion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: \- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
References
Publications (1)
- DERIVEDNicosia 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 39380737