A Multicenter, Prospective Study for Glioblastoma Patients

NCT07162324 | Not Yet Recruiting

• 1 other identifier: 27446
• Study Type: observational
• Target: 100
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Glioblastoma

Keywords

glioblastoma; lobectomy; complications; outcome; overall survival; progression free survival

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Overall survival of glioblastoma patients will be measured in months

  Five years

• Progression Free Survival

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

  Five years

Secondary Outcomes (4)

• Peri- and postoperative complications

  3 months

• Length of hospital stay

  30 days

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

  5 years

• Extent of Resection (EoR)

  up to 48 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glioblastoma patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Larissa University Hospital: lead
• University of Thessaly: collaborator
• University of California, San Francisco: collaborator
• University of Bern: collaborator

Study Sites (3)

UCSF Weil Institute for Neurosciences

San Francisco, California, 94143, United States

Location

University Hospital of Larissa

Larissa, Thessaly, 41100, Greece

Location

Inselspital University Hospital of Bern

Bern, 3010, Switzerland

Location

Related Publications (9)

• Arvaniti CK, Brotis AG, Young JS, Sivanrupan S, Menna G, Nishide M, Schucht P, Berger M, Fountas KN. The role of Lobectomy in Glioblastoma management: A Retrospective series. Brain Spine. 2025 Jun 18;5:104305. doi: 10.1016/j.bas.2025.104305. eCollection 2025.

  PMID: 40678087 BACKGROUND

• Arvaniti CK, Karagianni MD, Papageorgakopoulou MA, Brotis AG, Tasiou A, Fountas KN. The Role of Lobectomy in Glioblastoma Management. Adv Tech Stand Neurosurg. 2025;55:137-151. doi: 10.1007/978-3-031-90762-3_7.

  PMID: 40608104 BACKGROUND

• Arvaniti CK, Karagianni MD, Papageorgakopoulou MA, Brotis AG, Tasiou A, Fountas KN. The role of lobectomy in glioblastoma management: A systematic review and meta-analysis. Brain Spine. 2024 Apr 23;4:102823. doi: 10.1016/j.bas.2024.102823. eCollection 2024.

  PMID: 39285857 BACKGROUND

• Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016 Jun;131(6):803-20. doi: 10.1007/s00401-016-1545-1. Epub 2016 May 9.

  PMID: 27157931 BACKGROUND

• Wach J, Vychopen M, Kuhnapfel A, Seidel C, Guresir E. A Systematic Review and Meta-Analysis of Supramarginal Resection versus Gross Total Resection in Glioblastoma: Can We Enhance Progression-Free Survival Time and Preserve Postoperative Safety? Cancers (Basel). 2023 Mar 15;15(6):1772. doi: 10.3390/cancers15061772.

  PMID: 36980659 BACKGROUND

• Pessina F, Navarria P, Cozzi L, Ascolese AM, Simonelli M, Santoro A, Clerici E, Rossi M, Scorsetti M, Bello L. Maximize surgical resection beyond contrast-enhancing boundaries in newly diagnosed glioblastoma multiforme: is it useful and safe? A single institution retrospective experience. J Neurooncol. 2017 Oct;135(1):129-139. doi: 10.1007/s11060-017-2559-9. Epub 2017 Jul 8.

  PMID: 28689368 BACKGROUND

• Eyupoglu IY, Hore N, Merkel A, Buslei R, Buchfelder M, Savaskan N. Supra-complete surgery via dual intraoperative visualization approach (DiVA) prolongs patient survival in glioblastoma. Oncotarget. 2016 May 3;7(18):25755-68. doi: 10.18632/oncotarget.8367.

  PMID: 27036027 BACKGROUND

• Tripathi S, Vivas-Buitrago T, Domingo RA, Biase G, Brown D, Akinduro OO, Ramos-Fresnedo A, Sherman W, Gupta V, Middlebrooks EH, Sabsevitz DS, Porter AB, Uhm JH, Bendok BR, Parney I, Meyer FB, Chaichana KL, Swanson KR, Quinones-Hinojosa A. IDH-wild-type glioblastoma cell density and infiltration distribution influence on supramarginal resection and its impact on overall survival: a mathematical model. J Neurosurg. 2021 Oct 29;136(6):1567-1575. doi: 10.3171/2021.6.JNS21925. Print 2022 Jun 1.

  PMID: 34715662 BACKGROUND

• De Bonis P, Anile C, Pompucci A, Fiorentino A, Balducci M, Chiesa S, Lauriola L, Maira G, Mangiola A. The influence of surgery on recurrence pattern of glioblastoma. Clin Neurol Neurosurg. 2013 Jan;115(1):37-43. doi: 10.1016/j.clineuro.2012.04.005. Epub 2012 Apr 24.

  PMID: 22537870 BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Kostas Fountas, MD, PhD

  University Hospital of Larisa,Greece

  PRINCIPAL INVESTIGATOR

• Mitchel Berger, MD

  Department of Neurosurgery, UCSF

  STUDY DIRECTOR

• Philippe Schucht, MD, PhD

  University of Bern, Department of Neurosurgery

  STUDY CHAIR

Central Study Contacts

Kostas Fountas, MD, PhD

CONTACT

+306946989600; fountas@uth.gr

Christina Arvaniti, MD

CONTACT

+302413502786; arvanitixristina@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chairman

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CH (1); GR (1)