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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043232
• Other study ID #: KY2023-520
• Status: Recruiting
• Start date: September 2023
• Est. completion date: March 2026

Study information

• Verified date: September 2023
• Source: Huashan Hospital
• Contact: Di Chen, MD
• Phone: 86-021-5288-9999
• Email: dichen18[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

Biological:
• DC vaccine
DC vaccine produced by the Team

Locations

Country	Name	City	State
China	Huashan Hospital,Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

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