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临床试验/NCT03253107
NCT03253107招募中不适用

Postgenome-based Systemic Discovery of Strong Biomarkers Predict Gastric Cancer Chemotherapy Response

Kyungpook National University Hospital1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2015年11月30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
招募中
入组人数
800
试验地点
1
主要终点
Discovery of predicting bio-markers for gastric cancer chemotherapy response

研究概览

简要总结

  • discovery and validation of biomarker predicting gastric cancer chemotherapy response

  • Analysis for expression level of mRNA using Next generation sequencing in gastric cancer tissue by chemotherapy response

  • Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response

  • Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort

  • Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response

详细描述

  • discovery and validation of biomarker predicting gastric cancer chemotherapy response

  • Analysis for expression level of mRNA in fresh frozen gastric cancer tissue by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group Palliative chemotherapy (inoperable patients)

  • institutional primary Chemotherapy regimen (XP or Xelox)

  1. response group
  2. progression group

Post-OP adjuvant chemotherapy

  • institutional primary Chemotherapy regimen

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy
  • patients who agreed this study and voluntarily assigned the informed consents.

排除标准

  • patients who refused the study.
  • patients who have other cancers
  • heavy alcoholics

研究组 & 干预措施

responder in palliative chemotherapy

After initial chemotherapy, responder (complete remission, partial remission)

干预措施: Chemotherapy (Drug)

non-responder in palliative chemotherapy

After initial chemotherapy, disease progression

干预措施: Chemotherapy (Drug)

responder in adjuvant chemotherapy

complete cure and no recurrence at least 1 year after treatment

干预措施: Chemotherapy (Drug)

non-responder in adjuvant chemotherapy

non-complete cure or recurrence within 1 year after treatment

干预措施: Chemotherapy (Drug)

结局指标

主要结局

Discovery of predicting bio-markers for gastric cancer chemotherapy response

时间窗: up to 36 months

Discovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR

次要结局

  • Combination prediction model for palliative chemotherapy response in gastric cancer(up to 3 years)
  • Combination prediction model for adjuvant chemotherapy response in gastric cancer(up to 5 years)

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 Chilgok Hospital

研究点 (1)

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