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临床试验/NCT06461598
NCT06461598已完成不适用

Development and Validation of the ChemoResist Signature Precisely Predictive of Chemotherapy Sensitivity in Resected Pancreatic Ductal Adenocarcinoma

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 365 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
365
试验地点
1
主要终点
Overall survival

研究概览

简要总结

Pancreatic ductal adenocarcinoma (PDAC) is largely heterogeneous. We sought to develop and validate a signature to precisely predict chemotherapy sensitivity in PDAC. Genetic events of the four most commonly mutated genes in PDAC and expressions of 12 PI3K/AKT/mTOR pathway markers were examined in consecutive patients with PDAC. A 9-feature signature for prediction of chemotherapy benefits was constructed using the LASSO Cox regression model, and validated in two independent cohorts.

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

入选标准

  • ECOG performance status score of 0-1 before resection
  • complete clinicopathologic and follow-up data
  • availability of formalin-fixed paraffin-embedded (FFPE) specimens of resected primary tumor and hematoxylin and eosin slides with invasive tumor components

排除标准

  • any previous history of cancer
  • any anticancer therapy prior to resection or adjuvant radiotherapy
  • metastatic cases
  • major postsurgical complications with Clavien-Dindo Grade ≥2

研究组 & 干预措施

Training cohort

干预措施: Chemotherapy (Drug)

Validation cohort

干预措施: Chemotherapy (Drug)

结局指标

主要结局

Overall survival

时间窗: 3-year

Time between resection and death of any cause

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

lei huang

PI

Ruijin Hospital

研究点 (1)

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