Gene Signature Developed Using Machine Learning for Precise Prediction of Relapse and Survival in Resected Stage I-II Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The current TNM staging system is not sufficient for prediction of prognosis and cannot precisely identify the patients who are in greater need of adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC). Tumor mutation and copy number variation (CNV) markers may have a higher predictive value. In this study, whole exosome sequencing was performed for patients with stage I-II PDAC undergoing R0 resection. The investigators aimed to identify genes with discrepant statuses of mutations or CNVs between patients with and without relapse within 1 year after R0 resection, and then to construct a support vector machine (SVM)-based prognostic classifier (the SVM signature) for PDAC using machine learning; the investigators then aimed to further validate the SVM signature in an independent cohort.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Availability of hematoxylin and eosin slides with invasive tumor components
- •Availability of clinicopathologic characteristics and follow-up data
- •No previous history of cancer
排除标准
- •No formalin-fixed, paraffin-embedded (FFPE) tumor sample of primary tumor
- •Receipt of any neoadjuvant and/or adjuvant cancer-directed therapy
- •Survival time <3 months after resection
结局指标
主要结局
Overall survival
时间窗: 3-year
the time to death from any cause
Disease-free survival
时间窗: 3-year
the time to recurrence at any site or all-cause death, whichever occurred first
次要结局
未报告次要终点
研究者
Lei Huang
Research PI, Research Associate
Ruijin Hospital
