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TranscriptomicsNCT04792437

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

An observational study of Transcriptomics and Radiomics, run by Yu Yao, MD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Transcriptomics, Radiomics, Glioma
What is being tested?
surgery
Type of treatment
Surgery or procedure
How many people
120 participants
Where
1 siteChina
Study dates
10 Mar 2021to 30 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing glioma surgery at Huashan Hospital

Who may be able to join

  • 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 diagnosis was glioma;
  • 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;
  • Sign informed consent or ethics committee approval

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Huashan hospital， Fudan University

    Shanghai, 200040

    Yu Yao, 86-021-5288-9999, yu_yao03@126.com

    Recruiting

Other trials in China

About this study

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.
Being tested
surgery
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surgeryProcedure or surgery

    surgery

Study groups in NCT04792437
Study groupRoleWhat they receive
glioma patientsglioma patients with routine surgery
Receives: Procedure: surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival（OS），month

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

    Measured: 24 month

  2. Progress Free Survival （PFS），month

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

    Measured: 24 month

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

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

    Measured: 24 month

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

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

    Measured: 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.

    Measured: 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.

    Measured: 24 month

  7. expression level of DNA，drived from Metagenomics

    Differences about DNA expression of all microorganisms in the environment

    Measured: 24 month

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

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

    Measured: 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)

    Measured: 24month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start10 Mar 2021
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion30 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792437
Sponsor's protocol ID
KY2021-059
Status last verified
Mar 2021
First submitted
1 Mar 2021
Last updated
24 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Transcriptomics and Radiomics, run by Yu Yao, MD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival（OS），month (time frame: 24 month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04792437, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021; AzTrials last refreshed its copy on 26 Oct 2026.

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