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临床试验/NCT04792437
NCT04792437Unknown不适用

Research on Precise Immune Prevention and Treatment of Glioma Based on Multi-omics Sequencing Data

Yu Yao, MD1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年3月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
expression level of low molecular weight protein,drived from Metabonomics

研究概览

简要总结

This project intends to use multiple types of biological samples from glioma patients and mouse intracranial tumor models as research objects, and comprehensively apply a series of omics sequencing technologies and molecular biology technologies to jointly define the following research objectives :

详细描述

  1. Through high-throughput sequencing technologies such as, genome sequencing, transcriptome sequencing and single-cell sequencing, Proteomics,Metabonomics and Metagenomics, the similarities and differences of the glioma immune microenvironment within and between individuals were revealed from the multi-dimensional and big data level, and the immune molecular typing of glioma was established.
  2. Establish and verify that the neoantigen polypeptides predicted by AI algorithm after analyzing multi-omics data (genome, transcriptome, etc.) have good killing effect on individual tumor cells.
  3. To establish an intelligent evaluation model of glioma immunotyping by integrating imaging, pathology, high-throughput sequencing data and other omics information, and to provide a visual tool for monitoring changes in the intratumoral microenvironment of glioma patients, with the expectation of helping timely intervention of immunotherapy in patients with recurrence.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

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

入选标准

  • The patients with glioma in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled
  • They were 18-80 years old, male and female;
  • The pathological diagnosis was glioma;
  • On the basis of not affecting the clinical routine diagnosis, tissue (6 mm * 6 mm) or paraffin section (5 pieces) can be used for research;
  • Sign informed consent or ethics committee approval

排除标准

  • 未提供

结局指标

主要结局

expression level of low molecular weight protein,drived from Metabonomics

时间窗: 24 month

the expression level and interaction of different Metabolites,including D-2-Hydroxyglutarate. etc.

Reads Per Kilobase Million(RPKM),KB^(-1), drived from Transcriptome sequencing

时间窗: 24 month

the expression level of RNA,including mRNA、 miRNA、circRNA.etc

expression level of DNA,drived from Metagenomics

时间窗: 24 month

Differences about DNA expression of all microorganisms in the environment

Overall Survival(OS),month

时间窗: 24 month

Survival time from surgery to death in 120 patients with glioma.

expression level of protein,drived from paraffin-embedded specimens, retrospectively collected.

时间窗: 24month

different expression level of proteins in Gliomas with different grades and molecular subgroups (1000 cases)

Progress Free Survival (PFS),month

时间窗: 24 month

Survival time from surgery to first progression or death from any cause in patients with glioma.

Tumor Mutation Burden(TMB),mutations/mb, drived from Genomic sequencing

时间窗: 24 month

the level of gene mutation,including TERT、GMEM、IDH.etc.

expression level of protein , drived from Protein sequencing

时间窗: 24 month

the expression level of protein, post-translational modification and protein-protein interaction,including PD1、PDL1、CD4、CD8.etc.

frequency of TCR/BCR clone,drived from Immunomics

时间窗: 24month

different expression level and interaction of Immune molecules,including TCR、BCR、antibody.etc.

次要结局

未报告次要终点

研究者

发起方
Yu Yao, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yu Yao, MD

Professor

Huashan Hospital

研究点 (1)

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