NCT07627334

Brief Summary

Patients will receive in addition to standard histology analysis also the PDC- based drug screening.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
32mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Jan 2029

First Submitted

Initial submission to the registry

April 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

April 9, 2026

Last Update Submit

May 31, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients

    Percentage of patients receiving at least one day of maintenance systemic therapy in the timeframe of 4-6 weeks after completion of a short course radio(-chemo)therapy (40 Gy in 15 fractions)

    From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years

Secondary Outcomes (6)

  • PDC-based drug screening

    From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years

  • Quality of life assessment

    From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years

  • Neurocognitive function

    From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years

  • Overall survival

    From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years

  • Progression free survival

    From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years

  • +1 more secondary outcomes

Study Arms (1)

ex vivo drug screening

OTHER

Patients will receive in addition to standard histology analysis also the PDC-based drug screening.

Diagnostic Test: CBmed drug screening platform

Interventions

The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics

ex vivo drug screening

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG performance status 0-2
  • Newly diagnosed glioblastoma, IDH-wildtype - according to the 2021 WHO classification of Tumors of the Central Nervous System
  • Unmethylated MGMT promotor per local assessment
  • Scheduled short-course radiotherapy with or without concomitant temozolomide
  • Written informed consent

You may not qualify if:

  • Current participation in another therapeutic clinical trial.
  • Patients with a concurrent malignancy or malignancy within five years of study enrolment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma or stage I uterine cancer within the last 3 years.
  • Pregnant or lactating women.
  • Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection are eligible. Patients positive for anti-HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥350 cells/mm3, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended.
  • Participants who are unable or unwilling to comply with the requirements of the protocol as assessed by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AKH Vienna, Department for Internal Medicine I, Oncology

Vienna, State of Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.-Prof. PD DDr.

Study Record Dates

First Submitted

April 9, 2026

First Posted

June 4, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

June 4, 2026

Record last verified: 2026-05

Locations