NCT06845020|Not Yet Recruiting
CSF Proteomic Characterization of Glioblastomas
The Effects of CSF of Patients with Glioblastomas on the Microglial Immune Profile
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The Effects of CSF of Patients with Glioblastomas on the Microglial Immune Profile
Sponsor study identifier
observational
15
0 countries
N/A
Study Start
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this observational study is to identify proteins that can be found in the cerebrospinal fluid (CSF) of patients with grade IV brain tumors, specifically glioblastomas, and correlate these proteins with progression free survival, overall survival and performance status (functionality). All participants with high probability of glioblastoma will initially be included, final inclusion will be dependent on the definitive histopathological diagnosis of the tumor. The main question is: Can the researchers identify a proteomic profile in CSF from study participants with glioblastoma in association with a longer progression free survival? Participants will undergo the following procedures, that do not deviate from normal standard diagnostic care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 31, 2025
Actual (reported)February 25, 2025
Actual (reported)March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overall survival
The length of time the participants are still alive after tumor resection (initial recruitment date), including disease progression.
Measured at 3, 6, 9, and 12 months, after participant recruitment.
Progression free survival
Measured at 3, 6, 9, and 12 months, after participant recruitment.
Performance status
Measured at baseline, 3, 6, 9, and 12 months, after participant recruitment.
The cohort includes patients with a histopathological diagnosis of glioblastoma, defined by the 2021 guidelines: IDH-Wildtype diffuse and astrocytic glioma in adults \+ microvascular proliferation or necrosis OR + TERT promotor mutation OR + EFGR gene amplification OR + +7/-10 chromosome copy number changes.
Patient population includes patients who arrive at the Hospital Regional 'Dr. Valentin Gomez Farias' ISSSTE, who have a high probability of glioblastoma diagnosis, based on clinical presentation and imaging. Additionally the population includes 5 patients whose samples and information has already been stored at the Mayo Clinic Florida.
Schmid D, Warnken U, Latzer P, Hoffmann DC, Roth J, Kutschmann S, Jaschonek H, Rubmann P, Foltyn M, Vollmuth P, Winkler F, Seliger C, Felix M, Sahm F, Haas J, Reuss D, Bendszus M, Wildemann B, von Deimling A, Wick W, Kessler T. Diagnostic biomarkers from proteomic characterization of cerebrospinal fluid in patients with brain malignancies. J Neurochem. 2021 Jul;158(2):522-538. doi: 10.1111/jnc.15350. Epub 2021 Apr 9.
Skog J, Wurdinger T, van Rijn S, Meijer DH, Gainche L, Sena-Esteves M, Curry WT Jr, Carter BS, Krichevsky AM, Breakefield XO. Glioblastoma microvesicles transport RNA and proteins that promote tumour growth and provide diagnostic biomarkers. Nat Cell Biol. 2008 Dec;10(12):1470-6. doi: 10.1038/ncb1800. Epub 2008 Nov 16.
Cerebrospinal fluid, tumor tissue and blood serum
Maria Guadalupe Zavala Cerna, MD, PhD
Universidad Autónoma de Guadalajara
Hugo Guerrero Cazares, MD, PhD
Mayo Clinic Jacksonville, Florida.
First Submitted
January 31, 2025
First Posted
February 25, 2025
Study Start
March 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Clinical and Treatment Determinant of Prognosis in Glioblastoma
Contact the study team to confirm eligibility.
Schuhmann MU, Zucht HD, Nassimi R, Heine G, Schneekloth CG, Stuerenburg HJ, Selle H. Peptide screening of cerebrospinal fluid in patients with glioblastoma multiforme. Eur J Surg Oncol. 2010 Feb;36(2):201-7. doi: 10.1016/j.ejso.2009.07.010. Epub 2009 Aug 11.
Jayaram S, Gupta MK, Polisetty RV, Cho WC, Sirdeshmukh R. Towards developing biomarkers for glioblastoma multiforme: a proteomics view. Expert Rev Proteomics. 2014 Oct;11(5):621-39. doi: 10.1586/14789450.2014.939634. Epub 2014 Aug 13.
Kohata T, Ito S, Masuda T, Furuta T, Nakada M, Ohtsuki S. Laminin Subunit Alpha-4 and Osteopontin Are Glioblastoma-Selective Secreted Proteins That Are Increased in the Cerebrospinal Fluid of Glioblastoma Patients. J Proteome Res. 2020 Aug 7;19(8):3542-3553. doi: 10.1021/acs.jproteome.0c00415. Epub 2020 Jul 16.
Hori T, Sasayama T, Tanaka K, Koma YI, Nishihara M, Tanaka H, Nakamizo S, Nagashima H, Maeyama M, Fujita Y, Yokozaki H, Hirose T, Kohmura E. Tumor-associated macrophage related interleukin-6 in cerebrospinal fluid as a prognostic marker for glioblastoma. J Clin Neurosci. 2019 Oct;68:281-289. doi: 10.1016/j.jocn.2019.07.020. Epub 2019 Jul 18.
Miller AM, Shah RH, Pentsova EI, Pourmaleki M, Briggs S, Distefano N, Zheng Y, Skakodub A, Mehta SA, Campos C, Hsieh WY, Selcuklu SD, Ling L, Meng F, Jing X, Samoila A, Bale TA, Tsui DWY, Grommes C, Viale A, Souweidane MM, Tabar V, Brennan CW, Reiner AS, Rosenblum M, Panageas KS, DeAngelis LM, Young RJ, Berger MF, Mellinghoff IK. Tracking tumour evolution in glioma through liquid biopsies of cerebrospinal fluid. Nature. 2019 Jan;565(7741):654-658. doi: 10.1038/s41586-019-0882-3. Epub 2019 Jan 23.
Carrano A, Zarco N, Phillipps J, Lara-Velazquez M, Suarez-Meade P, Norton ES, Chaichana KL, Quinones-Hinojosa A, Asmann YW, Guerrero-Cazares H. Human Cerebrospinal Fluid Modulates Pathways Promoting Glioblastoma Malignancy. Front Oncol. 2021 Mar 4;11:624145. doi: 10.3389/fonc.2021.624145. eCollection 2021.
February 28, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 25, 2025
Record last verified: 2025-01
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