NCT04781764

Brief Summary

establishment of glioma microenvironment cell dynamic evolution database reveal the mechanism of GIM promoting malignant transformation of glioma cells reveal the dynamic regulation process of immune cells in the process of glioma evolution

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

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

Study Start

First participant enrolled

November 9, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

March 1, 2021

Last Update Submit

March 22, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Multi-omics characteristics of glioma patients

    we aim to describe patient's features about transcriptomics 、Immunomics、Radiomics ,etc.

    24 month

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

    different expression level of proteins in Gliomas with different grades and molecular subgroups (500 cases)

    24 month

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 results of frozen section during operation were gliomas (20 cases of who grade II, II and IV, respectively);
  • Tissue (6 mm \* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
  • Sign informed consent.

You may not qualify if:

  • Patients who meet any of the following criteria will not be included in this study:
  • Participants in other clinical trials;
  • Pregnant women.

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, Farah P, Ondracek A, Chen Y, Wolinsky Y, Stroup NE, Kruchko C, Barnholtz-Sloan JS. CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2006-2010. Neuro Oncol. 2013 Nov;15 Suppl 2(Suppl 2):ii1-56. doi: 10.1093/neuonc/not151. No abstract available.

    PMID: 24137015BACKGROUND
  • Wicki A, Mandala M, Massi D, Taverna D, Tang H, Hemmings BA, Xue G. Acquired Resistance to Clinical Cancer Therapy: A Twist in Physiological Signaling. Physiol Rev. 2016 Jul;96(3):805-29. doi: 10.1152/physrev.00024.2015.

    PMID: 27142452BACKGROUND
  • Ribas A, Wolchok JD. Cancer immunotherapy using checkpoint blockade. Science. 2018 Mar 23;359(6382):1350-1355. doi: 10.1126/science.aar4060. Epub 2018 Mar 22.

    PMID: 29567705BACKGROUND
  • Chen DS, Mellman I. Oncology meets immunology: the cancer-immunity cycle. Immunity. 2013 Jul 25;39(1):1-10. doi: 10.1016/j.immuni.2013.07.012.

    PMID: 23890059BACKGROUND
  • Gotwals P, Cameron S, Cipolletta D, Cremasco V, Crystal A, Hewes B, Mueller B, Quaratino S, Sabatos-Peyton C, Petruzzelli L, Engelman JA, Dranoff G. Prospects for combining targeted and conventional cancer therapy with immunotherapy. Nat Rev Cancer. 2017 May;17(5):286-301. doi: 10.1038/nrc.2017.17. Epub 2017 Mar 24.

    PMID: 28338065BACKGROUND
  • Kim PS, Armstrong TD, Song H, Wolpoe ME, Weiss V, Manning EA, Huang LQ, Murata S, Sgouros G, Emens LA, Reilly RT, Jaffee EM. Antibody association with HER-2/neu-targeted vaccine enhances CD8 T cell responses in mice through Fc-mediated activation of DCs. J Clin Invest. 2008 May;118(5):1700-11. doi: 10.1172/JCI34333.

    PMID: 18398507BACKGROUND
  • Peng W, Chen JQ, Liu C, Malu S, Creasy C, Tetzlaff MT, Xu C, McKenzie JA, Zhang C, Liang X, Williams LJ, Deng W, Chen G, Mbofung R, Lazar AJ, Torres-Cabala CA, Cooper ZA, Chen PL, Tieu TN, Spranger S, Yu X, Bernatchez C, Forget MA, Haymaker C, Amaria R, McQuade JL, Glitza IC, Cascone T, Li HS, Kwong LN, Heffernan TP, Hu J, Bassett RL Jr, Bosenberg MW, Woodman SE, Overwijk WW, Lizee G, Roszik J, Gajewski TF, Wargo JA, Gershenwald JE, Radvanyi L, Davies MA, Hwu P. Loss of PTEN Promotes Resistance to T Cell-Mediated Immunotherapy. Cancer Discov. 2016 Feb;6(2):202-16. doi: 10.1158/2159-8290.CD-15-0283. Epub 2015 Dec 8.

    PMID: 26645196BACKGROUND
  • Syed Khaja AS, Toor SM, El Salhat H, Faour I, Ul Haq N, Ali BR, Elkord E. Preferential accumulation of regulatory T cells with highly immunosuppressive characteristics in breast tumor microenvironment. Oncotarget. 2017 May 16;8(20):33159-33171. doi: 10.18632/oncotarget.16565.

    PMID: 28388539BACKGROUND
  • Watters JJ, Schartner JM, Badie B. Microglia function in brain tumors. J Neurosci Res. 2005 Aug 1;81(3):447-55. doi: 10.1002/jnr.20485.

    PMID: 15959903BACKGROUND

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

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 4, 2021

Study Start

November 9, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations