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临床试验/NCT03081988
NCT03081988招募中不适用

Prediction Model of Response for Combined Chemo-Radio-therapy Based on Clinical and Molecular Biology

Kyungpook National University Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2015年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
1
主要终点
Prediction model for CCRT response based on clinical and genetic molecular factors

研究概览

简要总结

  1. Retrospective review of old patients
  • Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015
  1. Prospective case-control study: RNA sequencing & miRNA microarray
  • naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy

  • acquirement of tissue, blood, clinical information

  • isolation of RNA, DNA, serum database of clinical & demographic information

***Analysis of mRNA sequencing / miRNA sequencing**** first analysis of RNA sequencing: bioinformatician second analysis of RNA sequencing: principle investigator 3. Experimental set for qPCR (esophageal tissue) study group 4. TMA for screened exon gene 5. validation set for qPCR (esophageal tissue) 6. follow-up of circulating miRNA in blood (baseline blood & post-CCRT blood 3M, 6M, 12M) 7. Prediction model for CCRT response in esophageal Cancer based on clinical and molecular factors 8. Validate the prediction model.

详细描述

  1. Retrospective review of old patients
  • Analysis of prediction factors for concomitant chemo-radiotherapy in locally advanced and advanced esophageal cancer from 2005 to 2015

Study Group

  1. non responder
  2. CR but recurrence
  3. CR and survival loner than 2 years
  4. Prospective case-control study: RNA sequencing & miRNA microarray
  • naive esophageal cancer patients who have a plan to receive concomitant chemo-radiotherapy --> acquirement of tissue, blood, clinical information --> isolation of RNA, DNA, serum database of clinical & demographic information

study group

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
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • locally advanced or advanced esophageal cancer who want concomitant chemoradiotherapy
  • persons who assigned the written informed consents.

排除标准

  • persons who did't assign the informed consents
  • other organ cancer
  • heavy alcoholics

结局指标

主要结局

Prediction model for CCRT response based on clinical and genetic molecular factors

时间窗: up to 36 months

prediction model for CCRT response based on clinical and genetic molecular factors in esophageal cancer

次要结局

  • banking of remained human material for post genetic & molecular study(up to 10 years)
  • tissue prediction marker for CCRT response and prognosis(up to 5 years)
  • circulating preditction marker for CCRT response and prognosis(up to 5 years)
  • in-vitro prediction of CCRT using primary esophageal cancer organoid(up to 6 month)

研究者

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

Su Youn Nam

Professor

Kyungpook National University Hospital

研究点 (1)

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