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临床试验/NCT05498194
NCT05498194Unknown不适用

Computational Prediction and Experimental Validation of Gastric Cancer Associated Neoantigens

University Medical Center Ho Chi Minh City (UMC)1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
The neoantigen landscape of patients with gastric cancer

研究概览

简要总结

This study is to develop methods for identification of neoantigens from patients with gastric cancer.

详细描述

Gastric cancer (GC) is the fourth most common cancer type and one of the leading causes of cancer-related death in Vietnam. Immunotherapy using checkpoint inhibitors (CPI) in combination with certain types of chemotherapy has been clinically shown to offer survival benefits for patients diagnosed with advanced stomach cancer. However, clinical outcomes of CPI are associated with the quantity as well as the quality of neoantigens which arise due to mutations in coding regions of cancer associated genes. Such neoantigens can be presentable by cancer cells to the host adaptive immune system and activate antitumor responses. Hence, the identification of neoantigens would be of significance for immunotherapeutic approaches. Recent data published by the Tumor Neoantigen Selection Alliance (TESLA) indicate that a large proportion (98%) of predicted neoantigens are not immunogenic and ineffective in activating anti-tumor responses. In the present study, we aim to develop a comprehensive pipeline incorporating both computational prediction tools and experimental validation assays to enhance the accuracy of neoantigen identification.

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
15 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female patients aged 15 years and older
  • Diagnosed with advanced gastric cancer (T2-4b/N0-3/M0-1 stage, according to the eighth edition of the American Joint Committee on Cancer TNM (AJCC TNM) system)
  • Treatment-Naive
  • Not known for other concomitant cancers
  • Provide written informed consent

排除标准

  • Insufficient tumor tissues (less than 1 cm3)
  • Unable to sign informed consent
  • Underwent treatment

结局指标

主要结局

The neoantigen landscape of patients with gastric cancer

时间窗: 3 months from the beginning of the study

The analysis of tumor DNA and RNA sequencing data will provide the mutational distribution of patients with gastric cancer, which could give rise to neoantigens. Of those, neoantigens derived from hotspot mutations in Vietnamese gastric cancer patients will be identified.

次要结局

  • The ratio of predicted neoantigens being presented by HLA-I(6 months from the beginning of the study)
  • The ratio of predicted neoantigens being immunogenic.(12 months from the beginning of the study)

研究者

发起方
University Medical Center Ho Chi Minh City (UMC)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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