NCT04179318Unknown不适用
A Retrospective, International Multicenter, Single Arm Clinical Trial of the New Geneswell BCT in Vitro Diagnosis of Breast Cancer Prognosis
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 100 人开始时间: 2020年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Comparative assessment between risk groups
研究概览
简要总结
Geneswell BCT is a precise and qualitative in vitro diagnostic test. The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group.
This test provides prognostic information to assess the risk of recurrence. The BCT score calculated by geneswell BCT was associated with the risk of recurrence. The higher the BCT score, the more likely it is to relapse, and vice versa.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patients were diagnosed with invasive breast cancer with positive hormone receptor (including positive estrogen receptor or progesterone receptor) and negative human epidermal growth factor receptor 2 (HER2)
- •Axillary lymph node assessment : pN0 or PN1
- •Women aged 18 and over
- •Patients without chemotherapy after operation
排除标准
- •Patients with negative hormone receptor （both estrogen and progesterone receptor are negative）
- •Human epidermal growth factor receptor 2 （HER2） positive
- •Pathological nodule evaluation: pN2 or pN3
- •Male patients
- •Patients receiving chemotherapy after surgery
结局指标
主要结局
Comparative assessment between risk groups
时间窗: Month 9
By evaluating the 5-year disease-free survival rate (DFS) of patients in high and low risk groups, the statistical differences between the two groups were compared.
次要结局
未报告次要终点
研究者
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