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

Sponsor
Huashan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06043232
Collaborator
(none)
360
1
30
12

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: DC vaccine

Study Design

Study Type:
Observational
Anticipated Enrollment :
360 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
The Role and Mechanism of MMR/MSI Phenotypes in Evaluating Vaccine Benefit in Glioblastoma
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Transcriptomics [36 months]

    The issues collected will be used for transcriptome sequencing to measure gene expression level.

  2. Immunomics [36 months]

    The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes

  3. Proteomics [36 months]

    The issues collected will be used for TCR/BCR sequencing to measure gene expression level in protein

  4. Radiomics [36 months]

    The features from images will be extracted using algorithm of Deep-learning or Radiomics

  5. IHC analysis [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.

  6. Genomics [36 months]

    The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Huashan Hospital,Fudan University Shanghai China 200040

Sponsors and Collaborators

  • Huashan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yu Yao, MD, Professor, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT06043232
Other Study ID Numbers:
  • KY2023-520
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yu Yao, MD, Professor, Huashan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023