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

Recruiting

• Conditions: Glioma
• Interventions: Biological: DC vaccine

• Registration Number: NCT06043232
• Lead Sponsor: Huashan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09
• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-12
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
glioma patients with DC vaccine	DC vaccine	surgery and DC vaccine

Primary Outcome Measures

Name	Time	Method
Radiomics	36 months	The features from images will be extracted using algorithm of Deep-learning or Radiomics
Transcriptomics	36 months	The issues collected will be used for transcriptome sequencing to measure gene expression level.
Immunomics	36 months	The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes
Genomics	36 months	The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.
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.
Proteomics	36 months	The issues collected will be used for TCR/BCR sequencing to measure gene expression level in protein

Trial Locations

Locations (1)

Huashan Hospital，Fudan University; 🇨🇳 Shanghai, China