Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- To determine the reliability and performance of the process and AI tool
研究概览
简要总结
TILs have been shown to be predictive for response to neo-adjuvant chemotherapy in patients with TNBC in multiple studies (Level-1B evidence for clinical validity as per REMARK criteria). TNBC patients with excellent survival outcome and low incidence of metastasis can be identified using a manual TIL score.
Furthermore, a fully end-to-end blinded evaluation of the same algorithm to be used in this study achieved >90% accuracy for predicting disease free survival (DFS) and overall survival (OS) in the pooled analysis of seven adjuvant phase-III TNBC trials.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Confirmed diagnosis of triple negative breast cancer (non-metastatic)
- •Planned for neo-adjuvant systemic therapy
- •Written consent to generic Tissue for Research donation
排除标准
- •Patients declined consent for generic Tissue for Research donation
结局指标
主要结局
To determine the reliability and performance of the process and AI tool
时间窗: 6 months
Success rate of digitization of H\&E slides \& Turnaround time for biomarker report within standard patient pathways
次要结局
未报告次要终点