A Multicenter, Prospective Study for Glioblastoma Patients

ConditionGlioblastoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLarissa University Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Overall Survival

Overall survival of glioblastoma patients will be measured in months

Time frame
Five years
2

Progression Free Survival

Progression Free Survival of glioblastoma patients will be measured in months.

Time frame
Five years

Secondary outcomes

1

Peri- and postoperative complications

Peri- and postoperative complications

Time frame
3 months
2

Length of hospital stay

Length of hospital stay, measured in days

Time frame
30 days
3

Preoperative and post operative Karnofsky Performance Scale (KPS) score (1-100)

Preoperative and post operative Karnofsky Performance Scale (KPS) score (1-100)

Time frame
5 years
4

Extent of Resection (EoR)

Extent of Resection (EoR) (% percentage of the preoperative tumor)

Time frame
up to 48 hours

Other outcomes

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

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