CSF Proteomic Characterization of Glioblastomas

February 21, 2025 updated by: Maria G. Zavala-Cerna, Univeridad Autonoma de Guadalajara

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

To successfully complete the study the following procedures will be implemented after obtaining informed consent:

  1. Serum blood sample acquisition and storage
  2. CSF sample acquisition Of all subjects included in the study a CSF sample will be taken. The sampling will be pre-surgical by lumbar puncture. Before the lumbar puncture all patients will undergo brain imaging (CT or MRI), as well as an fundoscopic exam and a blood draw. Through patient history and clinical examination other neurological pathology is discarded (neurological focalization, altered mental status, recent seizures or any other previous or recent neurological pathology). Patients with lumbar puncture contraindications as sampling method will undergo trans-surgical sampling, as initial procedure performed during surgery to avoid contamination. All sampling must be taken before any radio- and/or chemotherapy.
  3. Storage of sampled CSF The CSF sample obtained will be minimally 3 mL (3 tubes of 1 mL), in sterile tubes without any type of additives. The sample will be stored at -80 °C.
  4. Tumour tissue acquisition and storage Of all subjects included in the study, tumour tissue samples will be obtained from the central zone, posteriorly molecular analysis and identification of coding genes for significant proteins in CSF will be performed with MALDI-TOF.

After obtaining the patient background information and the tissue samples (CSF, tumour and serum) genetic and histological testing will be performed to obtain glioblastoma diagnosis, following current guidelines, the next parameters must be present for definitive glioblastoma diagnosis, and thus inclusion in the study:

1. 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. When definitive diagnosis is obtained and inclusion in this study is confirmed there will be programmed follow-up visits at 3, 6, 9 and 12 months, where a previously designed questionnaire similar to the admission questionnaire will be performed to specify patient evolution, and functionality current adjuvant treatment, additionally a full physical exam including neurological exam will be performed, with a radiological imaging study (CT or MRI). In case of decease, this will be closely registered by contacting the patient or family one week before the follow-up appointment to confirm the appointment, in case of deceasement date and cause must be registered.

Statistical Analysis:

For the descriptive phase of the statistical analysis, it is intended to use the mean and standard deviation for the variables with parametric distribution and the median with Interquartile range for the variables with non-parametric distribution. Qualitative variables such as protein identification will be reported in frequencies and percentages. The inferential phase includes the creation of contingency tables and chi square. For the analysis of progression-free survival and overall survival, Kaplan Meier curves will be used.

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Measured at 3, 6, 9, and 12 months, after participant recruitment.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: Measured at 3, 6, 9, and 12 months, after participant recruitment.

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).
Measured at 3, 6, 9, and 12 months, after participant recruitment.
Performance status
Time Frame: Measured at baseline, 3, 6, 9, and 12 months, after participant recruitment.
The Karnofsky performance status (KPS) will be used to measure the functionality of patients with cancer, and their ability to perform daily tasks. This be used this as a measurement of disease progression and to correlate different KPS with the proteomics found. The KPS scale measures patients performance on a scale from 0 to 100% with 10% intervals, 0% meaning patient deceased and 100% normal activity, without signs of disease.
Measured at baseline, 3, 6, 9, and 12 months, after participant recruitment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Univeridad Autonoma de Guadalajara

Collaborators

Mayo Clinic
Hospital Valentin Gomez Farias

Investigators

  • Principal Investigator: Maria Guadalupe Zavala Cerna, MD, PhD, Universidad Autónoma de Guadalajara
  • Study Chair: Hugo Guerrero Cazares, MD, PhD, Mayo Clinic Jacksonville, Florida.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 30, 2028

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T05-273-1324-4794-19-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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