The Study of Microglia/Macrophages Involved Dynamic Evolution of Glioma Microenvironment and the Function and Visualization of Targeted Molecules of Glioma

Glioma Clinical Trial

Official title:

The Study of Microglia/Macrophages Involved Dynamic Evolution of Glioma Microenvironment and the Function and Visualization of Targeted Molecules of Glioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781764
• Other study ID #: KY2020-009
• Status: Recruiting
• Start date: November 9, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Huashan Hospital
• Contact: Yu Yao
• Phone: 86-021-5288-9999
• Email: yu_yao03[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

To collect tissue samples from different stages of glioma evolution and establish a high-quality high-throughput sequencing database of immune microenvironment cells, so as to lay a data foundation for later mining the dialogue mechanism and key targets between immune cells and tumor cells in glioma microenvironment.

Based on the analysis results of the above database, the key role of key target molecules in the dialogue between GIM and glioma cells and the regulation ability of immune cells in the immune microenvironment were confirmed through cell and mouse animal experiments, which laid the foundation for later targeted drug research and development.

Combined with fluorescence imaging technology, through in vivo imaging of mice, it can provide more intuitive and effective visual verification for the dynamic infiltration process of GIM and other immune microenvironment cells in the process of glioma evolution, and provide a new theoretical basis for the visualization research of dynamic regulation of glioma immune microenvironment cells.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 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 results of frozen section during operation were gliomas (20 cases of who grade II, II and IV, respectively);

3. Tissue (6 mm * 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;

4. Sign informed consent.

Exclusion Criteria:

• Patients who meet any of the following criteria will not be included in this study:

1. Participants in other clinical trials;

2. Pregnant women.

Related Conditions & MeSH terms

• Glioma

Intervention

Procedure:
• surgery
surgery

Locations

Country	Name	City	State
China	Huashan Hospital,Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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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:ii1-56. doi: 10.1093/neuonc/not151. Erratum in: Neuro Oncol. 2014 May;16(5):760. — View Citation

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, Lizée 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. — View Citation

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Watters JJ, Schartner JM, Badie B. Microglia function in brain tumors. J Neurosci Res. 2005 Aug 1;81(3):447-55. Review. — View Citation

Wicki A, Mandalà 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multi-omics characteristics of glioma patients	we aim to describe patient's features about transcriptomics ?Immunomics?Radiomics ,etc.	24 month
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 (500 cases)	24 month