Clinical trial · Observational

CSF Proteomic Characterization of Glioblastomas

The Effects of CSF of Patients with Glioblastomas on the Microglial Immune Profile

NCT06845020CI-TRIAL-00086427not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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. 1. Lumbar puncture to obtain CSF. 2. Blood draw. 3. Trans-surgical tissue sample of the brain tumor. Additionally participants will be planned for follow up appointments every 3 months following the first 12 months after the surgical tumor resection.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Glioblastoma	Glioblastoma	CURATED_BROADER	0.80
Glioblastoma, Adult	Adult Glioblastoma	ONTOLOGY_EXACT	0.98
Glioblastoma (GBM)	Glioblastoma	CURATED_BROADER	0.80
Glioblastoma Multiforme of the Brain	Brain Glioblastoma	ALIAS	0.90
Glioblastoma WHO Grade IV	—	UNRESOLVED	—

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (1)

label
Patients with definitive diagnosis of glioblastoma
description
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.

Primary outcomes (1)

measure
Overall survival
timeFrame
Measured at 3, 6, 9, and 12 months, after participant recruitment.
description
The length of time the participants are still alive after tumor resection (initial recruitment date), including disease progression.

Secondary outcomes (2)

measure
Progression free survival
timeFrame
Measured at 3, 6, 9, and 12 months, after participant recruitment.
description
Progression free survival is defined by the amount of time the patient lives with glioblastoma from the start of treatment (surgical resection) without progression of disease. Progression of disease is defined as follows: an increase in tumor size, or; new cancerous lesiones on imaging, or; a non-measurable increase of malignant disease (eg.: paraneoplastic syndrome).

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Patients with confirmed diagnosis of glioblastoma (histopathological and molecular).
* Patients who voluntarily accept participation in this study.
* Patients aged 18 or older.

Exclusion Criteria:

* Patients who cannot be followed up at the Regional Hospital 'Dr. Valentin Gomez Farias' ISSSTE.
* Contamination of the required sample (CSF, serum, tumor).
* Patients with whom no sampling was obtained or subjects with incomplete background information.
* Patients who decide to withdraw participation from the study.

References

Publications (8)

BACKGROUNDSchmid 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. PMID 33735443
BACKGROUNDSkog 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. PMID 19011622
BACKGROUNDSchuhmann 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. PMID 19674866
BACKGROUNDJayaram 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. PMID 25115191
BACKGROUNDKohata 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. PMID 32628487
BACKGROUNDHori 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.