High-risk Breast Lesions: A Multicenter Retrospective Study

Ege University1,345 enrolled

Overview

In this multicenter study, the goal was to document the excisional biopsy or follow-up results of high risk lesions diagnosed on image guided CNB/VAB, and evaluate the clinical, imaging and histologic features for associated malignancy risk. The possibility of upgrade related to histologic subtype, tissue sampling and other variables was also evaluated.

This is a retrospective multicentric study that include 1345 patients from 30 centers. Patients who had a diagnosis of high risk lesions (HRL) on image guided core biopsy (tru-cut/vacuum biopsy) were reviewed in a 12 year period (between 2008 and 2020). The lesions included were ADH, LN (ALH/LCIS), papilloma (without or with atypia), RS, and FEA. The patients who managed with an excisional biopsy or having at least 1 year follow-up documentation following the diagnosis of borderline lesion were included in the study. Radiological findings, diameter of lesion (\>15 vs \<15 mm), needle biopsy type (14-16G vs 9-12G), sampling method and number of samplings (4 and \>4 vs \<4) were documented. IBM SPSS Version 25.0 statistical package program was used for analysis.

Study Type

OBSERVATIONAL

Enrollment

1,345

Conditions

Premalignant Lesion

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Study Population: The women with diagnosis of atypical ductal hyperplasia, lobular neoplasia, flat epithelial atypia, papilloma and radial scar on image guided core needle biopsy were studied Sampling Method: Non-Probability Sample Minimum Age: 12 Maximum Age: 86 Sex: Female Gender Based: No Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: * Image guided needle biopsy diagnosis * Atypical ductal hyperplasia * Lobular neoplasia * Flat epithelial atypia * Papilloma * Radial scar * Diagnosed on image guided needle biopsy Exclusion Criteria: * Fibroepithelial tumors * Mucocele like tumors * Diagnosed on surgical biopsy

Locations (1)

Ege University

Izmir, Turkey (Türkiye)

Outcomes

Primary Outcomes

upgrade rates related to histologic subtype, tissue sampling and other variables

the results from excisional biopsy or at least 1 year follow-up documentation

Time frame: one year

Data from ClinicalTrials.gov

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