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RecruitingNCT06043232Updated Sep 21, 2023

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

An observational study in Glioma, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Huashan Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
360
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Glioma

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Keywords

  • Glioblastoma multiforme
  • DC vaccine
  • Mismatch repair
  • Microsatellite instability
  • Biomarker
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In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

This study's planned enrollment of 360 is above the median of 88 across 238 observational studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing glioma surgery at Huashan Hospital

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

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.
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Study design

Observational model
Other
Time perspective
Other
Enrollment
360 participants (estimated)
Patient registry
No

Groups and cohorts

  • glioma patients with routine surgery

    surgery

  • glioma patients with DC vaccine

    surgery and DC vaccine

    Biological: DC vaccine

Interventions

  • BiologicalDC vaccine

    DC vaccine produced by the Team

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What researchers measure

Primary outcomes

  1. Transcriptomics

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

    Time frame: 36 months

  2. Immunomics

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

    Time frame: 36 months

  3. Proteomics

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

    Time frame: 36 months

  4. Radiomics

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

    Time frame: 36 months

  5. 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.

    Time frame: 36 months

  6. Genomics

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

    Time frame: 36 months

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Study locations

1 of 1 sites recruiting
  • Huashan Hospital,Fudan University
    Shanghai, 200040, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06043232
Lead sponsor
Huashan Hospital
Responsible party
Yu Yao, MD (Professor, Huashan Hospital) — Principal investigator
First posted
Sep 21, 2023
Start date
Sep 2023 (estimated)
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Sep 21, 2023

Study contacts

Di Chen, MD
Contact
dichen18@fudan.edu.cn
86-021-5288-9999

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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