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临床试验/NCT05441189
NCT05441189已完成不适用

Gene Signature Developed Using Machine Learning for Precise Prediction of Relapse and Survival in Resected Stage I-II Pancreatic Ductal Adenocarcinoma

The Fourth Affiliated Hospital of Anhui Medical University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年4月19日最近更新:
适应症

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

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

发起方
The Fourth Affiliated Hospital of Anhui Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lei Huang

Research PI, Research Associate

Ruijin Hospital

研究点 (1)

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