About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (>18 years of age) with
Glioblastoma based on radiographic features,
Patients that consent for study participation.
Disqualifiers
Non adult patients,
Patients that do not consent for participation in this study,
Patients with other CNS tumors
Trial population
Glioblastoma patients
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Overall Survival
Overall survival of glioblastoma patients will be measured in months
Progression Free Survival
Progression Free Survival of glioblastoma patients will be measured in months.
Secondary outcomes
Peri- and postoperative complications
Peri- and postoperative complications
Length of hospital stay
Length of hospital stay, measured in days
Preoperative and post operative Karnofsky Performance Scale (KPS) score (1-100)
Preoperative and post operative Karnofsky Performance Scale (KPS) score (1-100)
Extent of Resection (EoR)
Extent of Resection (EoR) (% percentage of the preoperative tumor)
Sponsors and contacts
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Larissa University Hospital
Lead sponsor
University of Thessaly
Collaborator
University of California, San Francisco
Collaborator
University of Bern
Collaborator
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