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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06043232
Other study ID # KY2023-520
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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