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GlioblastomaNCT07162324

A Multicenter, Prospective Study for Glioblastoma Patients

An observational study of Glioblastoma, run by Larissa University Hospital at 3 sites in 3 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
How many people
100 participants
Where
3 sitesin 3 countries
Study dates
1 Sep 2025to 31 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Glioblastoma patients

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Kostas Fountas, MD, PhD contact

+306946989600

fountas@uth.gr

Christina Arvaniti, MD contact

+302413502786

arvanitixristina@hotmail.com

3 sites in 3 countries

United States1 site
  • UCSF Weil Institute for Neurosciences

    San Francisco, California, 94143

    Mitchel Berger, MD, 415-353-7500, Mitchel.berger@ucsf.edu

    Jacob Young, MD, +4153537500, jacob.young@ucsf.edu

Other trials in United States

Greece1 site
  • University Hospital of Larissa

    Larissa, Thessaly, 41100

    Kostas Fountas, MD, PhD, +306946989600, fountas@uth.gr

    Christina Arvaniti, MD, +306984085769, arvanitixristina@hotmail.com

Other trials in Greece

Switzerland1 site
  • Inselspital University Hospital of Bern

    Bern, 3010

    Philippe Schucht, MD, PhD, +41316327671, philippe.schucht@insel.ch

    Sivani Sivanrupan, MD, +41316327671, sivani.sivanrupan@insel.ch

Other trials in Switzerland

About this study

Official title: Prognostic Factors, Surgical Management and Survival of Glioblastoma Patients: a Multicenter Prospective Study

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.

Read the detailed description

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).

Conditions
Glioblastoma
Keywords
glioblastoma, lobectomy, complications, outcome, overall survival, progression free survival
Medical subject headings
Glioblastoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival of glioblastoma patients will be measured in months

    Measured: Five years

  2. Progression Free Survival

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

    Measured: Five years

Secondary outcomes (4)
  1. Peri- and postoperative complications

    Peri- and postoperative complications

    Measured: 3 months

  2. Length of hospital stay

    Length of hospital stay, measured in days

    Measured: 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)

    Measured: 5 years

  4. Extent of Resection (EoR)

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

    Measured: up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07162324
Sponsor's protocol ID
27446
Status last verified
Sep 2025
First submitted
6 Aug 2025
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40678087
  • 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.

    PubMed 40608104
  • 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.

    PubMed 39285857
  • 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.

    PubMed 27157931
  • 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.

    PubMed 36980659
  • 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.

    PubMed 28689368
  • 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.

    PubMed 27036027
  • 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.

    PubMed 34715662
  • 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.

    PubMed 22537870

Questions about this trial

What is this clinical trial studying?

An observational study of Glioblastoma, run by Larissa University Hospital at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Greece, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kostas Fountas, MD, PhD (+306946989600, fountas@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Five years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07162324, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.

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