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Status unknownNCT04792437Updated Mar 24, 2021

Research on Precise Immune Prevention and Treatment of Glioma Based on Multi-omics Sequencing Data

An observational study in Transcriptomics, Radiomics and Glioma, sponsored by Yu Yao, MD. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-24.

Sponsored by Yu Yao, MD · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
120
Ages
18 Years to 80 Years
Sex
All
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Study summary

This project intends to use multiple types of biological samples from glioma patients and mouse intracranial tumor models as research objects, and comprehensively apply a series of omics sequencing technologies and molecular biology technologies to jointly define the following research objectives :

Read the detailed description
  1. Through high-throughput sequencing technologies such as， genome sequencing, transcriptome sequencing and single-cell sequencing, Proteomics，Metabonomics and Metagenomics， the similarities and differences of the glioma immune microenvironment within and between individuals were revealed from the multi-dimensional and big data level, and the immune molecular typing of glioma was established.
  2. Establish and verify that the neoantigen polypeptides predicted by AI algorithm after analyzing multi-omics data (genome, transcriptome, etc.) have good killing effect on individual tumor cells.
  3. To establish an intelligent evaluation model of glioma immunotyping by integrating imaging, pathology, high-throughput sequencing data and other omics information, and to provide a visual tool for monitoring changes in the intratumoral microenvironment of glioma patients, with the expectation of helping timely intervention of immunotherapy in patients with recurrence.
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Conditions studied

  • Transcriptomics
  • Radiomics
  • Glioma

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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 120 is above the median of 88 across 238 observational studies indexed under Glioma.

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Lead sponsor

This is the only study on the registry with Yu Yao, MD as lead sponsor.

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
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 diagnosis was glioma;
    3. On the basis of not affecting the clinical routine diagnosis, tissue (6 mm * 6 mm) or paraffin section (5 pieces) can be used for research;
    4. Sign informed consent or ethics committee approval

Exclusion criteria

Exclusion Criteria:

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Study design

Observational model
Other
Time perspective
Other
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • glioma patients

    glioma patients with routine surgery

    Procedure: surgery

Interventions

  • Proceduresurgery

    surgery

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What researchers measure

Primary outcomes

  1. Overall Survival（OS），month

    Survival time from surgery to death in 120 patients with glioma.

    Time frame: 24 month

  2. Progress Free Survival （PFS），month

    Survival time from surgery to first progression or death from any cause in patients with glioma.

    Time frame: 24 month

  3. Tumor Mutation Burden（TMB），mutations/mb, drived from Genomic sequencing

    the level of gene mutation，including TERT、GMEM、IDH.etc.

    Time frame: 24 month

  4. Reads Per Kilobase Million（RPKM），KB^(-1), drived from Transcriptome sequencing

    the expression level of RNA,including mRNA、 miRNA、circRNA.etc

    Time frame: 24 month

  5. expression level of protein , drived from Protein sequencing

    the expression level of protein, post-translational modification and protein-protein interaction，including PD1、PDL1、CD4、CD8.etc.

    Time frame: 24 month

  6. expression level of low molecular weight protein，drived from Metabonomics

    the expression level and interaction of different Metabolites，including D-2-Hydroxyglutarate. etc.

    Time frame: 24 month

  7. expression level of DNA，drived from Metagenomics

    Differences about DNA expression of all microorganisms in the environment

    Time frame: 24 month

  8. frequency of TCR/BCR clone，drived from Immunomics

    different expression level and interaction of Immune molecules，including TCR、BCR、antibody.etc.

    Time frame: 24month

  9. expression level of protein，drived from paraffin-embedded specimens， retrospectively collected.

    different expression level of proteins in Gliomas with different grades and molecular subgroups (1000 cases)

    Time frame: 24month

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Study locations

1 of 1 sites recruiting
  • Huashan hospital， Fudan University
    Shanghai, 200040, China
    Recruiting
08

References and documents

Publications

  • Ostrom QT, Gittleman H, Truitt G, Boscia A, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2011-2015. Neuro Oncol. 2018 Oct 1;20(suppl_4):iv1-iv86. doi: 10.1093/neuonc/noy131. No abstract available. Erratum In: Neuro Oncol. 2018 Nov 17. doi: 10.1093/neuonc/noy171. PubMed 30445539 ↗
  • Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9. PubMed 19269895 ↗
  • Tan AC, Ashley DM, Lopez GY, Malinzak M, Friedman HS, Khasraw M. Management of glioblastoma: State of the art and future directions. CA Cancer J Clin. 2020 Jul;70(4):299-312. doi: 10.3322/caac.21613. Epub 2020 Jun 1. PubMed 32478924 ↗
  • Chheda ZS, Kohanbash G, Okada K, Jahan N, Sidney J, Pecoraro M, Yang X, Carrera DA, Downey KM, Shrivastav S, Liu S, Lin Y, Lagisetti C, Chuntova P, Watchmaker PB, Mueller S, Pollack IF, Rajalingam R, Carcaboso AM, Mann M, Sette A, Garcia KC, Hou Y, Okada H. Novel and shared neoantigen derived from histone 3 variant H3.3K27M mutation for glioma T cell therapy. J Exp Med. 2018 Jan 2;215(1):141-157. doi: 10.1084/jem.20171046. Epub 2017 Dec 4. PubMed 29203539 ↗
  • Nejo T, Matsushita H, Karasaki T, Nomura M, Saito K, Tanaka S, Takayanagi S, Hana T, Takahashi S, Kitagawa Y, Koike T, Kobayashi Y, Nagae G, Yamamoto S, Ueda H, Tatsuno K, Narita Y, Nagane M, Ueki K, Nishikawa R, Aburatani H, Mukasa A, Saito N, Kakimi K. Reduced Neoantigen Expression Revealed by Longitudinal Multiomics as a Possible Immune Evasion Mechanism in Glioma. Cancer Immunol Res. 2019 Jul;7(7):1148-1161. doi: 10.1158/2326-6066.CIR-18-0599. Epub 2019 May 14. PubMed 31088845 ↗
  • Keskin DB, Anandappa AJ, Sun J, Tirosh I, Mathewson ND, Li S, Oliveira G, Giobbie-Hurder A, Felt K, Gjini E, Shukla SA, Hu Z, Li L, Le PM, Allesoe RL, Richman AR, Kowalczyk MS, Abdelrahman S, Geduldig JE, Charbonneau S, Pelton K, Iorgulescu JB, Elagina L, Zhang W, Olive O, McCluskey C, Olsen LR, Stevens J, Lane WJ, Salazar AM, Daley H, Wen PY, Chiocca EA, Harden M, Lennon NJ, Gabriel S, Getz G, Lander ES, Regev A, Ritz J, Neuberg D, Rodig SJ, Ligon KL, Suva ML, Wucherpfennig KW, Hacohen N, Fritsch EF, Livak KJ, Ott PA, Wu CJ, Reardon DA. Neoantigen vaccine generates intratumoral T cell responses in phase Ib glioblastoma trial. Nature. 2019 Jan;565(7738):234-239. doi: 10.1038/s41586-018-0792-9. Epub 2018 Dec 19. PubMed 30568305 ↗
  • Hilf N, Kuttruff-Coqui S, Frenzel K, Bukur V, Stevanovic S, Gouttefangeas C, Platten M, Tabatabai G, Dutoit V, van der Burg SH, Thor Straten P, Martinez-Ricarte F, Ponsati B, Okada H, Lassen U, Admon A, Ottensmeier CH, Ulges A, Kreiter S, von Deimling A, Skardelly M, Migliorini D, Kroep JR, Idorn M, Rodon J, Piro J, Poulsen HS, Shraibman B, McCann K, Mendrzyk R, Lower M, Stieglbauer M, Britten CM, Capper D, Welters MJP, Sahuquillo J, Kiesel K, Derhovanessian E, Rusch E, Bunse L, Song C, Heesch S, Wagner C, Kemmer-Bruck A, Ludwig J, Castle JC, Schoor O, Tadmor AD, Green E, Fritsche J, Meyer M, Pawlowski N, Dorner S, Hoffgaard F, Rossler B, Maurer D, Weinschenk T, Reinhardt C, Huber C, Rammensee HG, Singh-Jasuja H, Sahin U, Dietrich PY, Wick W. Actively personalized vaccination trial for newly diagnosed glioblastoma. Nature. 2019 Jan;565(7738):240-245. doi: 10.1038/s41586-018-0810-y. Epub 2018 Dec 19. Erratum In: Nature. 2019 Feb;566(7745):E13. doi: 10.1038/s41586-019-0959-z. PubMed 30568303 ↗
  • Li Y, Liu X, Xu K, Qian Z, Wang K, Fan X, Li S, Wang Y, Jiang T. MRI features can predict EGFR expression in lower grade gliomas: A voxel-based radiomic analysis. Eur Radiol. 2018 Jan;28(1):356-362. doi: 10.1007/s00330-017-4964-z. Epub 2017 Jul 28. PubMed 28755054 ↗
  • Grossmann P, Gutman DA, Dunn WD Jr, Holder CA, Aerts HJ. Imaging-genomics reveals driving pathways of MRI derived volumetric tumor phenotype features in Glioblastoma. BMC Cancer. 2016 Aug 8;16:611. doi: 10.1186/s12885-016-2659-5. PubMed 27502180 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2021, 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
NCT04792437
Lead sponsor
Yu Yao, MD
Responsible party
Yu Yao, MD (Professor, Huashan Hospital) — Sponsor-investigator
First posted
Mar 11, 2021
Start date
Mar 10, 2021
Primary completion
Sep 30, 2022 (estimated)
Completion
Sep 30, 2022 (estimated)
Last update
Mar 24, 2021

Oversight

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

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