A Multicenter, Prospective Study for Glioblastoma Patients

Study Purpose

Glioblastoma (GBM) is the most common and aggressive primary tumor of the adult central nervous system (CNS), with a poor prognosis and median overall survival ranging between 14 to 20 months despite advancements in diagnostic and therapeutic strategies. This prospective, observational, multicenter study aims to collect and analyze comprehensive data from GBM patients treated across selected centers in Europe and the United States, the investigators' centers included. Information will include demographics, imaging findings, molecular subtypes, clinical status, surgical strategies, postoperative management, complications, and follow-up data. Patients over 18 years old with radiographic evidence of GBM who provide informed consent will be included. Surgical interventions will vary, ranging from biopsy to supramaximal resections, based on individual patient and surgeon decisions. Key outcomes of interest include overall survival (OS) and progression-free survival (PFS). Secondary endpoints include perioperative complications, extent of resection (EoR), pre- and postoperative Karnofsky Performance Scores (KPS), hospital stay duration, and identification of risk factors influencing OS and functional outcomes. Patient monitoring will include standardized follow-up at one, three, and six months postoperatively, and quarterly thereafter or as clinically indicated. Statistical analysis will be conducted using R software, applying descriptive statistics, chi-square tests, logistic and linear regression, and assessing statistical significance at p < 0.05. Results will also be expressed in odds ratios with 95% confidence intervals. This study seeks to define optimal surgical strategies based on patient-specific factors and contribute to improved, personalized treatment pathways for GBM management.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria:

  • - Adult patients (>18 years of age) with.
  • - Glioblastoma based on radiographic features, - Patients that consent for study participation.

Exclusion criteria:

- Non adult patients, - Patients that do not consent for participation in this study, - Patients with other CNS tumors

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07162324
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Larissa University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kostas Fountas, MD, PhDMitchel Berger, MDPhilippe Schucht, MD, PhD
Principal Investigator Affiliation University Hospital of Larisa,GreeceDepartment of Neurosurgery, UCSFUniversity of Bern, Department of Neurosurgery
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Greece, Switzerland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

Brief Background: Glioblastoma remains the most prevalent and aggressive primary tumor of the Central Nervous system (CNS) in adults, with dismal prognosis and median overall survival between 14 to 20 months, despite the current advances in diagnostics and treatment options. Aim: The aim of this study is to collect data prospectively in all glioblastoma patients treated in centers across Europe and the United States (US). In this data there will be included information regarding demographics, imaging, molecular subtypes, preoperative clinical status, surgical strategy in these patients, and post-operative management, along with any complications. Eventually this data will be assessed in order to distinguish the best surgical approach, according to different groups of patients (e.g. age, molecular subtype, tumor locations etc). Furthermore, treatment effect, tumor pseudo-progression, and recurrence management will also be assessed. Study Design: This project constitutes a prospective, observational, multicenter study. The centers included are staffed with multiple experienced neurooncology surgeons. Patients will undergo a thorough demographic, family and medical history, and clinical examination. The patients' imaging studies will also be assessed. After the surgical management chosen, each patient will be closely monitored postoperatively until discharge. Postoperative imaging, postoperative neurological evaluation, and any complications will be thoroughly documented. Pathology reports, along with information regarding molecular subtypes will be included. The patients will be re-evaluated at one, three, and six months postoperatively, and then every three months or sooner in cases of any suspicion of recurrence or any changes in the patient's clinical status. Patients: The investigators will include patients fulfilling the following eligibility criteria: Inclusion criteria:

  • - Adult patients (>18 years of age) with.
  • - Glioblastoma based on radiographic features (Magnetic Resonance Imaging), - Patients that consent for study participation.
Exclusion criteria:
  • - Non adult patients (<18 years of age), - Patients that do not consent for participation in this study, - Patients with other CNS tumors (primary or secondary).
Intervention: Patients with tumors, compatible with glioblastomas -according to conventional Magnetic Resonance Imaging (MRI)- will fulfil their written consent and will then be included in the study. Each patient will be treated with a different surgical management (e.g biopsy, subtotal resection, gross-total resection, supramaximal resection or lobectomy) according to surgeons' and/or patients' choice. Any adjunct treatment will be documented (such as chemotherapy or/and radiotherapy). Outcome: The primary endpoints of the study are:
  • (1) The overall survival (OS) of the patients (2) The progression free survival (PFS) of the patients.
OS and PFS will be calculated in months. The secondary endpoints of the study are:
  • (1) Peri- and post-operative complications, (2) Length of hospital stay counted in days, (3) Preoperative and postoperative Karnofsky Performance Scale (KPS) score (1-100), and (4) Extent of Resection (EoR) (counted as the % percentage of the preoperative tumor).
Co-registration of:
  • (1) Risk factors affecting OS and PFS ( patient's age, cerebral dominance, BMI, tumor's molecular subtype),(2) Age (measured in years), (3) Gender (male, female, other), (4) Other demographic information (such as nationality, education level), (5) Anatomic location of the tumor, (6) Size of the tumor before intervention (measured in cm), (7) Intake of mannitol, hypertonic saline or steroids, (8) Dexterity, (9) Symptoms at the time of hospital admission, and (10) Molecular subtype of the tumor.
Timing: Follow up: one month, six months, and then every three months postoperatively. In cases of tumor recurrence or post-discharge complications patients will be reassessed. Enrollment of the first patient will take place after approval by the IRB and Research registration. Indicative time period: 2025
  • - 2030.
Statistical analysis: Descriptive statistics will be used to summarize count and continuous data. In particular, count data will be presented in absolute numbers and percentages, while continuous data will be given in mean (and standard deviation) or median values (and interquartile ranges) according to the Kolmogorov test. We will also use the chi-square test and logistic regression (or Kruskal-Wallis test), and linear regression to test for between-group differences. Statistical significance will be set at 0.05. All statistical analyses will be carried out in R statistical environment. For count data the results will also be provided in odds ratio along with their 95% confidence interval (CI).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSF Weil Institute for Neurosciences, San Francisco 5391959, California 5332921

Status

Address

UCSF Weil Institute for Neurosciences

San Francisco 5391959, California 5332921, 94143

Site Contact

Mitchel Berger, MD

[email protected]

415-353-7500

International Sites

University Hospital of Larissa, Larissa 258576, Thessaly 6697809, Greece

Status

Address

University Hospital of Larissa

Larissa 258576, Thessaly 6697809, 41100

Site Contact

Kostas Fountas, MD, PhD

[email protected]

+306946989600

Inselspital University Hospital of Bern, Bern 2661552, Switzerland

Status

Address

Inselspital University Hospital of Bern

Bern 2661552, , 3010

Site Contact

Philippe Schucht, MD, PhD

[email protected]

+41316327671

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