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临床试验/NCT03161392
NCT03161392已完成不适用

Evaluation of Solitary Dilated Duct Visualized by Mammography in Correlation With Ultrasonography and Anatomopathological Findings.

Faculdade de Medicina do ABC0 个研究点目标入组 135 人开始时间: 2016年3月16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
135
主要终点
Abnormal histological finding at breast biopsy

研究概览

简要总结

Mammograms performed at the Diagnostic Imaging Department of the "Instituto Brasileiro de Controle do Câncer" (IBCC - Brazilian Cancer Control Institute) will be prospectively evaluated. Patients who present a solitary dilated duct visualized by mammography will be submitted to breast ultrasonography. In case of detection of lesion, a percutaneous biopsy will be performed.

详细描述

Purpose: To determinate the incidence, pathological significance and risk factors associated with the presence of solitary dilated duct visualized at mammography exam.

Methods: Mammograms performed at the Diagnostic Imaging Department of the "Instituto Brasileiro de Controle do Câncer" (IBCC - Brazilian Cancer Control Institute) will be prospectively evaluated. Patients who present a solitary dilated duct visualized by mammography will be included in the study. These patients will be recalled in order to be submitted to an ultrasonography directed to the mammographic finding. Patients who present lesions on ultrasonography will undergo method-guided percutaneous biopsy.

Patients with ductal ectasia, without evident lesions, will be followed for 2 years to evaluate stability by means of mammography or ultrasonography every 6-month intervals.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Identification of a solitary dilated breast duct at mammography

排除标准

  • Previous breast surgery at same side of detection of dilated duct

结局指标

主要结局

Abnormal histological finding at breast biopsy

时间窗: At guided-percutaneous biopsy

Detection of any histological abnormality

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

Luciano de Melo Pompei'

Professor

Faculdade de Medicina do ABC

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