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临床试验/NCT03669952
NCT03669952已完成不适用

Longitudinal Observational Study About the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer

Omphis Foundation0 个研究点目标入组 464 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
464
主要终点
Recurrence

研究概览

简要总结

A prospective observational longitudinal study of 464 patients was performed between 2010 and 2015. Patients with invasive ductal carcinoma (IDC) and ductal carcinoma in situ associated to invasive ductal carcinoma (DCIS +IDC) were included and analyzed.

详细描述

Type of study:

A prospective observational longitudinal study was performed on patients who had undergone curative surgery for primary invasive breast cancer between 2010 and 2015. The study was performed in a single breast pathology unit [Alt Penedés hospital and Sant Camil hospital(GAP)]. Only patients with a definitive histopathology-based diagnostic of ductal carcinoma were included. Patients diagnosed with metastasis were excluded. Patients with bilateral breast cancer were included as two independent study cases.

Patients:

Sample size calculation: 191. A total of 464 patients were included in the study. IDC was present in 221 patients (47.6%) and IDC + DCIS was present in 243 patients (52.4%).

Data collected included clinical characteristics (age, laterality and clinical symptoms at the time of diagnostic), histopathological information (tumor size, tumor grade, hormone receptors, nodal status, HER-2 mutation (erb-b2 receptor tyrosine kinase 2), number of ki67, presence and percentage of DCIS, grade of DCIS, and surrogate subtype) and surgical procedure performed.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with invasive ductal carcinoma of the breast
  • Patients who received surgery for primary invasive breast cancer between 2010 and 2015

排除标准

  • Patients with metastasis at the diagnostic

结局指标

主要结局

Recurrence

时间窗: Patients included between 2010 and 2015 will be follow up til January of 2018 with a mean follow up of 51.43 months

Neoplasm metastasis, either local or distant recurrence of the invasive ductal carcinoma

次要结局

未报告次要终点

研究者

发起方
Omphis Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Lopez Gordo

Specialists in General Surgery

Omphis Foundation

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