Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The success rate in obtaining the Genomic Grade Index in clinical practice
研究概览
简要总结
In this prospective study the investigators sought to evaluate the feasibility of using the genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact on treatment recommendations.
详细描述
The primary objective of this study was to evaluate the feasibility of implementing Genomic Grade Index (GGI) in community hospitals in Belgium for breast cancer patients with node negative and 1-3 node positive early breast cancer. GGI would be considered a feasible genomic test if results were obtained in > 70% of evaluated patients.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive breast cancer meeting the following criteria:
- •T1, T2, or operable T3 disease
- •Zero to three positive lymph nodes and no distant metastases
- •Operable disease - Must have undergone breast-conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance
排除标准
- •No other invasive cancer within the past 5 years except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer
- •No psychological, familial, sociological, or geographical condition that would preclude entering into a clinical study
结局指标
主要结局
The success rate in obtaining the Genomic Grade Index in clinical practice
时间窗: 12 months
To evaluate the feasibility of implementing Genomic Grade Index in community hospitals in Belgium for breast cancer patients diagnosed with node negative and 1-3 node positive early-stage invasive breast cancer
次要结局
- The impact of Genomic Grade Index results on adjuvant treatment decision(12 months)