MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas

September 12, 2023 updated by: Yu Yao, MD, Huashan Hospital

The Role and Mechanism of MMR/MSI Phenotypes in Evaluating Vaccine Benefit in Glioblastoma

Glioblastoma (GBM) is the most malignant primary intracranial tumor with a median survival of about 18 months, and new therapies are urgently needed. Tumor vaccines has been shown to improve survival of GBM, but not all patients can benefit from vaccine treatment and biomarkers are urgently needed. Deletion of mismatch repair (MMR) protein and microsatellite instability (MSI) state are important features in the biological evolution of GBM, and may be used as markers for tumor vaccine. Therefore, this project will collect samples from GBM patients before and after vaccine treatment respectively, and evaluate the role of MMR/MSI gene phenotype in predicting vaccine efficacy and the potential molecular mechanism. Moreover, MMR/MSI phenotypes will be assessed by deep-learning and radiomics using images to establish noninvasive markers for vaccine.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

360

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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 with routine surgery
surgery
glioma patients with DC vaccine
surgery and DC vaccine
Biological: DC vaccine
DC vaccine produced by the Team

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcriptomics
Time Frame: 36 months
The issues collected will be used for transcriptome sequencing to measure gene expression level.
36 months
Immunomics
Time Frame: 36 months
The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes
36 months
Proteomics
Time Frame: 36 months
The issues collected will be used for TCR/BCR sequencing to measure gene expression level in protein
36 months
Radiomics
Time Frame: 36 months
The features from images will be extracted using algorithm of Deep-learning or Radiomics
36 months
IHC analysis
Time Frame: 36 months
Different expression level of proteins (CD3,CD8,B7-H4, MMR proteins) in Gliomas with different grades and molecular subgroups (300 cases) will be measured using immunohistochemical.
36 months
Genomics
Time Frame: 36 months
The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.
36 months

Collaborators and Investigators

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

Sponsor

Huashan Hospital

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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-520

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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