Clinical trial

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

Name
KY2023-520
Description
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.
Trial arms
Trial start
2023-09-01
Estimated PCD
2026-03-01
Trial end
2026-03-01
Status
Recruiting
Treatment
DC vaccine
DC vaccine produced by the Team
Arms:
glioma patients with DC vaccine
Size
360
Primary endpoint
Transcriptomics
36 months
Immunomics
36 months
Proteomics
36 months
Radiomics
36 months
IHC analysis
36 months
Genomics
36 months
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 360, 'type': 'ESTIMATED'}}
Updated at
2023-09-21

1 organization

1 product

1 indication

Organization
Huashan Hospital
Product
DC vaccine
Indication
Glioma