CSF Proteomic Characterization of Glioblastomas

NCT06845020 | Not Yet Recruiting

• 1 other identifier: T05-273-1324-4794-19-00
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Lumbar puncture to obtain CSF.
2. 2.Blood draw.
3. 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

Glioblastoma; Glioblastoma WHO Grade IV; Glioblastoma (GBM); Glioblastoma Multiforme of the Brain; Glioblastoma, Adult

Keywords

Glioblastoma; Cerebrospinal fluid; CSF; GBM; Proteomics; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• 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.

Study Arms (1)

Patients with definitive diagnosis of glioblastoma

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Univeridad Autonoma de Guadalajara: lead
• Mayo Clinic: collaborator
• Hospital Valentin Gomez Farias: collaborator

Related Publications (8)

• 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.

  PMID: 33735443 BACKGROUND

• 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.

  PMID: 19011622 BACKGROUND

• 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.

  PMID: 19674866 BACKGROUND

• 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.

  PMID: 25115191 BACKGROUND

• 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.

  PMID: 32628487 BACKGROUND

• 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.

  PMID: 31327593 BACKGROUND

• 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.

  PMID: 30675060 BACKGROUND

• 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.

  PMID: 33747938 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid, tumor tissue and blood serum

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Maria Guadalupe Zavala Cerna, MD, PhD

  Universidad Autónoma de Guadalajara

  PRINCIPAL INVESTIGATOR

• Hugo Guerrero Cazares, MD, PhD

  Mayo Clinic Jacksonville, Florida.

  STUDY CHAIR

Central Study Contacts

Maria Guadalupe Zavala Cerna, MD, PhD

CONTACT

+523336488824; maria.cerna@edu.uag.mx

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Development in Health Sciences

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 25, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: February 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share