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临床试验/NCT04926688
NCT04926688已完成不适用

Outcome of High-risk Breast Lesions Diagnosed on Image-guided Core Needle Biopsy: Results From a Multicenter Retrospective Study

Ege University1 个研究点 分布在 1 个国家目标入组 1,345 人开始时间: 2020年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,345
试验地点
1
主要终点
upgrade rates related to histologic subtype, tissue sampling and other variables

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • Fibroepithelial tumors
  • Mucocele like tumors
  • Diagnosed on surgical biopsy

结局指标

主要结局

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

时间窗: one year

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysenur Oktay

Professor

Ege University

研究点 (1)

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