Ikke-invasiv hjernetumor molekylær diagnostikk og overvåking
Ikke-invasiv hjernesvulstdiagnose gjennom analyse av proksimale væsker, sirkulerende tumorceller og biomolekyler
This prospective multicenter study aims to enroll GBM patients who will undergo repeated assessments (preoperatively and 3 months post-surgery) to detect circulating tumor cells and analyze the transcriptomic profiles of EVs in their blood. The prognostic and monitoring significance of these biomarkers to disease course (assessing treatment efficacy, resistance incidence, tumor progression) will be evaluated.
Concurrently, proteomic profiles typical of GBM will be analyzed in blood and ocular secretion samples from GBM patients, patients with low-grade gliomas, and patients without brain tumors to identify and validate novel protein biomarkers suitable for disease monitoring. Additionally, this study proposes an innovative approach to monitor GBM patients by investigating the presence of GBM-specific nucleic acid fragments in urine.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Josef Srovnal, MD,PhD
- Telefonnummer: +420585632137
- E-post: josef.srovnal@upol.cz
Studer Kontakt Backup
- Navn: Ondrej Kalita, MD,PhD
- Telefonnummer: +420588443568
- E-post: ondrej.kalita@fnol.cz
Studiesteder
-
-
-
Olomouc, Tsjekkia, 77900
- Rekruttering
- Department of Neurosurgery, University Hospital Olomouc
-
Ta kontakt med:
- Ondrej Kalita, MD, PhD
- Telefonnummer: +420588443568
- E-post: ondrej.kalita@fnol.cz
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Inhabitants of Olomouc region
Beskrivelse
Inclusion Criteria: Adult patients with brain tumors -
Exclusion Criteria: No other cancer; no inflammatory disease
-
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Glioblastoma multiforme
Patients with GBM |
No intervention among the arms. The diagnostic, prognostic, predictive and follow-up value of tested biomolecules will be analyzed. |
|
Low-grade glioma
Patients with low-grade gliomas. |
No intervention among the arms. The diagnostic, prognostic, predictive and follow-up value of tested biomolecules will be analyzed. |
|
Control group
Patients without cancer or systemic inflammation |
No intervention among the arms. The diagnostic, prognostic, predictive and follow-up value of tested biomolecules will be analyzed. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proteomic profiles of proximal liquids in brain tumor patients
Tidsramme: 2020-2023
|
The protein profiles will be measured in ocular secretion and plasma samples of patients wiht GBM, low-grade glioma and control cohort. Candidate proteins will be correleted with clinical parameters. The number of patients with identified prognostic biomarkers will be reported. |
2020-2023
|
|
Circulating tumor cells (CTCs) for non-invasive monitoring of GBM patients.
Tidsramme: 2020-2030
|
The number of CTCs and their molecular characteristics will be measured in peripheral blod of GBM patients. The CTCs counts will be correleted with the clinical parameters. The number of patients with the presence or absence of CTCs will be reported. |
2020-2030
|
|
Extracellular vesicles (EVs) for non-invasive monitoring of GBM patients.
Tidsramme: 2020-2030
|
The RNA profiles of EVs will be measured in plasma samples of patients wiht GBM. Candidate RNAs will be correleted with clinical parameters. The number of patients with identified prognostic RNAs will be reported. |
2020-2030
|
|
Urine as a source of GBM-specific nucleic acids fragments for disease monitoring.
Tidsramme: 2025-2030
|
The GBM-specific nucleic acids fragments will be measured in urine of GBM patients. Candidate nucleic acids will be correleted with clinical parameters. The number of patients with identified prognostic biomolecules will be reported. |
2025-2030
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Marian Hajduch, MD,PhD, Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NW25-03-00198
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Anonymous proteomic profiles of plasma and ocular secretion and transcriptomic data from extracelular vesicles will be shared.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .