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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04792437
Other study ID # KY2021-059
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 10, 2021
Est. completion date September 30, 2022

Study information

Verified date March 2021
Source Huashan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 :


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
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 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:

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
surgery
surgery

Locations

Country Name City State
China Huashan hospital, Fudan University Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Yu Yao, MD

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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, Martínez-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, Piró J, Poulsen HS, Shraibman B, McCann K, Mendrzyk R, Löwer 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-Brück A, Ludwig J, Castle JC, Schoor O, Tadmor AD, Green E, Fritsche J, Meyer M, Pawlowski N, Dorner S, Hoffgaard F, Rössler 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. — View Citation

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, Allesøe 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, Suvà 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Tan AC, Ashley DM, López 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival(OS),month Survival time from surgery to death in 120 patients with glioma. 24 month
Primary Progress Free Survival (PFS),month Survival time from surgery to first progression or death from any cause in patients with glioma. 24 month
Primary Tumor Mutation Burden(TMB),mutations/mb, drived from Genomic sequencing the level of gene mutation,including TERT?GMEM?IDH.etc. 24 month
Primary Reads Per Kilobase Million(RPKM),KB^(-1), drived from Transcriptome sequencing the expression level of RNA,including mRNA? miRNA?circRNA.etc 24 month
Primary 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. 24 month
Primary expression level of low molecular weight protein,drived from Metabonomics the expression level and interaction of different Metabolites,including D-2-Hydroxyglutarate. etc. 24 month
Primary expression level of DNA,drived from Metagenomics Differences about DNA expression of all microorganisms in the environment 24 month
Primary frequency of TCR/BCR clone,drived from Immunomics different expression level and interaction of Immune molecules,including TCR?BCR?antibody.etc. 24month
Primary 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) 24month
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