Clinical trial NCT04792437: Research on Precise Immune Prevention and Treatment of Glioma Based on Multi-omics Sequencing Data
Official title: Research on Precise Immune Prevention and Treatment of Glioma Based on Multi-omics Sequencing Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transcriptomics
Radiomics
Glioma
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing glioma surgery at Huashan Hospital

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.

Eligibility criteria: 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:

Primary outcomes:
measure: Overall Survival（OS），month
timeFrame: 24 month
measure: Progress Free Survival （PFS），month
timeFrame: 24 month
measure: Tumor Mutation Burden（TMB），mutations/mb, drived from Genomic sequencing
timeFrame: 24 month
measure: Reads Per Kilobase Million（RPKM），KB^(-1), drived from Transcriptome sequencing
timeFrame: 24 month
measure: expression level of protein , drived from Protein sequencing
timeFrame: 24 month
measure: expression level of low molecular weight protein，drived from Metabonomics
timeFrame: 24 month
measure: expression level of DNA，drived from Metagenomics
timeFrame: 24 month
measure: frequency of TCR/BCR clone，drived from Immunomics
timeFrame: 24month
measure: expression level of protein，drived from paraffin-embedded specimens， retrospectively collected.
timeFrame: 24month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan hospital， Fudan University
Study officials:
References:
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