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

Fudan University

Status: Enrolling

Conditions: Glioma

Treatments: Biological: DC vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT06043232

KY2023-520

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

360 participants in 2 patient groups

glioma patients with routine surgery

Description:

surgery

glioma patients with DC vaccine

Description:

surgery and DC vaccine

Treatment:

Biological: DC vaccine