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| Name | Class |
|---|---|
| Ministero della Salute, Italy | OTHER |
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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).
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.
Patients 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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no excisional biopsy | Other | Patients in this arm underwent to an initial sequence of sampling (less than 4 g of tissue sampled) |
|
| excisional biosy | Experimental | Patients in this arm will undergo a second sequence of biopsy samples (at least 4g sampled) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum-assisted excisional biopsy | Procedure | at least 4g of tissue sampled (excisional biopsy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Nicosia, MD | Contact | +390294372449 | luca.nicosia@ieo.it | |
| Claudia Sangalli, MSc | Contact | claudia.sangalli@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Luca Nicosia, MD | European Institute of Oncology IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS | Recruiting | Milan | 20141 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39380737 | Derived | 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. |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Not excisional biopsy | Procedure | biopsy with less than 4 g of tissue sampled |
|
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |