Longitudinal Observational Study About the Influence of Ductal Carcinoma in Situ on the Outcome of Invasive Breast Cancer
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
- 否
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
Sandra Lopez Gordo
Specialists in General Surgery
Omphis Foundation
