Excisional Vacuum-Assisted Breast Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma and/or DCIS in Patients Diagnosed With Intraductal Papilloma Without Atypia or Flat Epithelial Atypia by Core Needle Biopsy

NCT02489617

Flat Epithelia Atypia Intraductal Papilloma Without Atypia

COMPLETED NA

Diagnosis of Pathological Complete Response by Vacuum-assisted Biopsy After Neoadjuvant Chemotherapy in Breast Cancer

NCT02948764

Breast Neoplasms

COMPLETED NA

Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma

NCT02988765

Vulvar Cancer

UNKNOWN NA

Adenocarcinoma of the Uterine Cervix and HPV

NCT05267834

Adenocarcinoma of the Uterine Cervix

COMPLETED

Pilot Study for the Generation of Cervical Cancer Organoids From Patients Undergoing Diagnostic Biopsy

NCT07248878

Cervical Cancer Stage IB2 Cervical Cancer Stage IIa Cervical Cancer Stage IB +1 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atypical Ductal Hyperplasia Ductal Carcinoma in Situ

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

no excisional biopsy

Patients in this arm underwent to an initial sequence of sampling (less than 4 g of tissue sampled)

Group Type OTHER

Not excisional biopsy

Intervention Type PROCEDURE

biopsy with less than 4 g of tissue sampled

excisional biosy

Patients in this arm will undergo a second sequence of biopsy samples (at least 4g sampled)

Group Type EXPERIMENTAL

Vacuum-assisted excisional biopsy

Intervention Type PROCEDURE

at least 4g of tissue sampled (excisional biopsy)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vacuum-assisted excisional biopsy

at least 4g of tissue sampled (excisional biopsy)

Intervention Type PROCEDURE

Not excisional biopsy

biopsy with less than 4 g of tissue sampled

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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