NCT06043232

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

September 5, 2023

Last Update Submit

September 12, 2023

Conditions

Glioma

Keywords

Glioblastoma multiformeDC vaccineMismatch repairMicrosatellite instabilityBiomarker

Outcome Measures

Primary Outcomes (6)

  • Transcriptomics

    The issues collected will be used for transcriptome sequencing to measure gene expression level.

    36 months

  • Immunomics

    The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes

    36 months

  • Proteomics

    The issues collected will be used for TCR/BCR sequencing to measure gene expression level in protein

    36 months

  • Radiomics

    The features from images will be extracted using algorithm of Deep-learning or Radiomics

    36 months

  • 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

  • Genomics

    The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.

    36 months

Study Arms (2)

glioma patients with routine surgery

surgery

glioma patients with DC vaccine

surgery and DC vaccine

Biological: DC vaccine

Interventions

DC vaccineBIOLOGICAL

DC vaccine produced by the Team

glioma patients with DC vaccine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing glioma surgery at Huashan Hospital

You may qualify if:

  • 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
  • They were 18-80 years old, male and female;
  • The pathological results of frozen section during operation were gliomas (20 cases of who grade II, II and IV, respectively);
  • Tissue (6 mm \* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
  • Sign informed consent.

You may not qualify if:

  • Patients who meet any of the following criteria will not be included in this study:
  • Participants in other clinical trials;
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital，Fudan University

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

GliomaGlioblastomaMicrosatellite Instability

Interventions

lentiviral minigene vaccine of COVID-19 coronavirus

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAstrocytomaGenomic InstabilityPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Di Chen, MD

CONTACT

86-021-5288-9999dichen18@fudan.edu.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 21, 2023

Study Start

September 1, 2023

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)