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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06043232
Enrollment
360
Registered
2023-09-21
Start date
2023-09-30
Completion date
2026-03-31
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

Keywords

Glioblastoma multiforme, DC vaccine, Mismatch repair, Microsatellite instability, Biomarker

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.

Interventions

BIOLOGICALDC vaccine

DC vaccine produced by the Team

Sponsors

Huashan Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Transcriptomics36 monthsThe issues collected will be used for transcriptome sequencing to measure gene expression level.
Immunomics36 monthsThe issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes
Proteomics36 monthsThe issues collected will be used for TCR/BCR sequencing to measure gene expression level in protein
Radiomics36 monthsThe features from images will be extracted using algorithm of Deep-learning or Radiomics
IHC analysis36 monthsDifferent 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.
Genomics36 monthsThe issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.

Countries

China

Contacts

Primary ContactDi Chen, MD
dichen18@fudan.edu.cn86-021-5288-9999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026