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

March 22, 2021 updated by: Yu Yao, MD
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 :

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing glioma surgery at Huashan Hospital

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
glioma patients
glioma patients with routine surgery
Procedure: surgery
surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival（OS），month
Time Frame: 24 month
Survival time from surgery to death in 120 patients with glioma.
24 month
Progress Free Survival （PFS），month
Time Frame: 24 month
Survival time from surgery to first progression or death from any cause in patients with glioma.
24 month
Tumor Mutation Burden（TMB），mutations/mb, drived from Genomic sequencing
Time Frame: 24 month
the level of gene mutation，including TERT、GMEM、IDH.etc.
24 month
Reads Per Kilobase Million（RPKM），KB^(-1), drived from Transcriptome sequencing
Time Frame: 24 month
the expression level of RNA,including mRNA、 miRNA、circRNA.etc
24 month
expression level of protein , drived from Protein sequencing
Time Frame: 24 month
the expression level of protein, post-translational modification and protein-protein interaction，including PD1、PDL1、CD4、CD8.etc.
24 month
expression level of low molecular weight protein，drived from Metabonomics
Time Frame: 24 month
the expression level and interaction of different Metabolites，including D-2-Hydroxyglutarate. etc.
24 month
expression level of DNA，drived from Metagenomics
Time Frame: 24 month
Differences about DNA expression of all microorganisms in the environment
24 month
frequency of TCR/BCR clone，drived from Immunomics
Time Frame: 24month
different expression level and interaction of Immune molecules，including TCR、BCR、antibody.etc.
24month
expression level of protein，drived from paraffin-embedded specimens， retrospectively collected.
Time Frame: 24month
different expression level of proteins in Gliomas with different grades and molecular subgroups (1000 cases)
24month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yu Yao, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 7, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2021-059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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