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Excisional Vacuum-Assisted Breast Biopsy

NCT05932758 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-07-21

No results posted yet for this study

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).

Conditions

  • Atypical Ductal Hyperplasia
  • Ductal Carcinoma in Situ

Interventions

PROCEDURE

Vacuum-assisted excisional biopsy

at least 4g of tissue sampled (excisional biopsy)

PROCEDURE

Not excisional biopsy

biopsy with less than 4 g of tissue sampled

Sponsors & Collaborators

  • Ministero della Salute, Italy

    collaborator OTHER

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Luca Nicosia, MD · European Institute of Oncology IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-17
Primary Completion
2025-04-30
Completion
2025-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05932758 on ClinicalTrials.gov