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Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening: Advanced Brain Tumor TheRApy Clinical Trial In Patients Scheduled for shOrt Course radiatioN (ATTRACTION)

31. maj 2026 opdateret af: Anna Berghoff, Medical University of Vienna
Patients will receive in addition to standard histology analysis also the PDC- based drug screening.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients will receive in addition to standard histology analysis also the PDC- based drug screening. The PDC-based drug screening will be performed only in accordance with the approved Performance Study Plan on subjects who have signed an informed consent form. Execution of the PDC-based drug screening is limited to the approved study investigators. Based on the results of the PDC-based drug screening, a molecular tumor board will formulate a personalized treatment approach. The personalized treatment recommendation will be communicated to the patient. Application of adjuvant

/ maintenance therapy will be evaluated to evaluate the proportion of patients scheduled for a reduced course of radio(-chemo)therapy fit enough to receive at least one day of systemic therapy.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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
  • Successful PDC establishment and PDCs available for drug screening - based on inclusion in one of the following studies: (EK Nrs. (a) Medical University of Graz: 32-650 ex 19/20; (b) Medical University of Vienna: 1407/2021; (c) Karl Landsteiner University of Health Sciences: GS1-EK-4/823-2022; (d) Kepler University Hospital Linz: 1323/2022; (e) Medical University of Innsbruck 1003/2023) and follow-up ethics covering the establishment of an Austrian GlioBank (EK Nrs. (a) Medical University of Graz: 36-253 ex 23/24; (b) Medical University of Vienna: 2186/2023; (c) Karl Landsteiner University of Health Sciences: GS3-EK-1/211-2024; (d) Kepler University Hospital Linz: 1002/2024; (e) Medical University of Innsbruck 1095/2024)
  • Scheduled short-course radiotherapy with or without concomitant temozolomide
  • Written informed consent
  • No exclusion criteria

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: ex vivo drug screening
Patients will receive in addition to standard histology analysis also the PDC-based drug screening.
Diagnostisk test: CBmed drug screening platform
The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of patients
Tidsramme: 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
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PDC-based drug screening
Tidsramme: 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
Assess feasibility of a PDC-based drug screening approach in a multi-center study hroughout Austria and within the timeframe 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
Quality of life assessment
Tidsramme: 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 based on verified questionnaires
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
Tidsramme: 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
Assess the neurocognitive function using the NANO scale (neurological assessment in neuro- oncology)
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
Tidsramme: 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
Assess the 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
Tidsramme: 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
Assess the 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
Geriatric screening tools
Tidsramme: 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
Geriatric vulnerability will be assessed using the Geriatric-8 (G8) and Vulnerable Elders Survey 13 (VES-13) screening tools.
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University of Vienna

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

9. april 2026

Først indsendt, der opfyldte QC-kriterier

31. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ATTRACTION

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Glioblastom (GBM)

Kliniske forsøg med CBmed drug screening platform

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