High-risk Breast Lesions: A Multicenter Retrospective Study

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

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Recruitment Status

COMPLETED

Total Enrollment

1345 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-10

Study Completion Date

2021-06-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Premalignant Lesion

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Image guided needle biopsy diagnosis
* Atypical ductal hyperplasia
* Lobular neoplasia
* Flat epithelial atypia
* Papilloma
* Radial scar
* Diagnosed on image guided needle biopsy