CSF Proteomic Characterization of Glioblastomas

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniveridad Autonoma de Guadalajara

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with confirmed diagnosis of glioblastoma (histopathological and molecular).

Patients who voluntarily accept participation in this study.

Patients aged 18 or older.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

15 Participants
are grouped into 1 trial group
Group A: Patients with definitive diagnosis of glioblastoma

Trial outcomes

Primary outcomes

1

Overall survival

The length of time the participants are still alive after tumor resection (initial recruitment date), including disease progression.

Time frame
Measured at 3, 6, 9, and 12 months, after participant recruitment.

Secondary outcomes

1

Progression free survival

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).

Time frame
Measured at 3, 6, 9, and 12 months, after participant recruitment.
2

Performance status

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.

Time frame
Measured at baseline, 3, 6, 9, and 12 months, after participant recruitment.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Univeridad Autonoma de Guadalajara

Lead sponsor

Mayo Clinic

Collaborator

Hospital Valentin Gomez Farias

Collaborator

This trial is not recruiting at the moment. You can still explore other options: