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

• Conditions: Transcriptomics; Radiomics; Glioma

• Registration Number: NCT04792437
• Lead Sponsor: Yu Yao, MD

Brief Summary

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 :

Detailed Description

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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-07
• Study Start: 2021-03-10
• Study First Posted: 2021-03-11
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-24
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

  1. They were 18-80 years old, male and female;
  2. The pathological diagnosis was glioma;
  3. 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;
  4. Sign informed consent or ethics committee approval

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
expression level of low molecular weight protein，drived from Metabonomics	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	24 month	the expression level of RNA,including mRNA、 miRNA、circRNA.etc
expression level of DNA，drived from Metagenomics	24 month	Differences about DNA expression of all microorganisms in the environment
Overall Survival（OS），month	24 month	Survival time from surgery to death in 120 patients with glioma.
expression level of protein，drived from paraffin-embedded specimens， retrospectively collected.	24month	different expression level of proteins in Gliomas with different grades and molecular subgroups (1000 cases)
Progress Free Survival （PFS），month	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	24 month	the level of gene mutation，including TERT、GMEM、IDH.etc.
expression level of protein , drived from Protein sequencing	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	24month	different expression level and interaction of Immune molecules，including TCR、BCR、antibody.etc.

Trial Locations

Locations (1)

Huashan hospital， Fudan University; 🇨🇳 Shanghai, China