The Study of Microglia/Macrophages Involved Dynamic Evolution of Glioma Microenvironment and the Function and Visualization of Targeted Molecules of Glioma

March 22, 2021 updated by: Yu Yao, MD, Huashan Hospital
establishment of glioma microenvironment cell dynamic evolution database reveal the mechanism of GIM promoting malignant transformation of glioma cells reveal the dynamic regulation process of immune cells in the process of glioma evolution

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To collect tissue samples from different stages of glioma evolution and establish a high-quality high-throughput sequencing database of immune microenvironment cells, so as to lay a data foundation for later mining the dialogue mechanism and key targets between immune cells and tumor cells in glioma microenvironment.

Based on the analysis results of the above database, the key role of key target molecules in the dialogue between GIM and glioma cells and the regulation ability of immune cells in the immune microenvironment were confirmed through cell and mouse animal experiments, which laid the foundation for later targeted drug research and development.

Combined with fluorescence imaging technology, through in vivo imaging of mice, it can provide more intuitive and effective visual verification for the dynamic infiltration process of GIM and other immune microenvironment cells in the process of glioma evolution, and provide a new theoretical basis for the visualization research of dynamic regulation of glioma immune microenvironment cells.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Contact

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 results of frozen section during operation were gliomas (20 cases of who grade II, II and IV, respectively);
    3. Tissue (6 mm * 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
    4. Sign informed consent.

Exclusion Criteria:

  • Patients who meet any of the following criteria will not be included in this study:

    1. Participants in other clinical trials;
    2. Pregnant women.

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
Multi-omics characteristics of glioma patients
Time Frame: 24 month
we aim to describe patient's features about transcriptomics 、Immunomics、Radiomics ，etc.
24 month
expression level of protein，drived from paraffin-embedded specimens， retrospectively collected.
Time Frame: 24 month
different expression level of proteins in Gliomas with different grades and molecular subgroups (500 cases)
24 month

Collaborators and Investigators

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

Sponsor

Huashan Hospital

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)

November 9, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 4, 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

  • KY2020-009

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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