NCT04792437

Brief 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 :

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 1, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

March 1, 2021

Last Update Submit

March 22, 2021

Conditions

TranscriptomicsRadiomicsGlioma

Outcome Measures

Primary Outcomes (9)

  • Overall Survival（OS），month

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

    24 month

  • Progress Free Survival （PFS），month

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

    24 month

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

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

    24 month

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

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

    24 month

  • 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

  • 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

  • expression level of DNA，drived from Metagenomics

    Differences about DNA expression of all microorganisms in the environment

    24 month

  • frequency of TCR/BCR clone，drived from Immunomics

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

    24month

  • 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

Study Arms (1)

glioma patients

glioma patients with routine surgery

Procedure: surgery

Interventions

surgeryPROCEDURE

surgery

glioma patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan hospital， Fudan University

Shanghai, 200040, China

RECRUITING

Related Publications (9)

  • 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.

    PMID: 30445539BACKGROUND

  • 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.

    PMID: 19269895BACKGROUND

  • 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.

    PMID: 32478924BACKGROUND

  • 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.

    PMID: 29203539BACKGROUND

  • 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.

    PMID: 31088845BACKGROUND

  • 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.

    PMID: 30568305BACKGROUND

  • 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.

    PMID: 30568303BACKGROUND

  • 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.

    PMID: 28755054BACKGROUND

  • 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.

    PMID: 27502180BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood、urine、feces、Glioma tissue、brain tissue、meninges、Cerebrospinal fluid

MeSH Terms

Conditions

Glioma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

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

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 11, 2021

Study Start

March 10, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)