Prognostiske biomarkører hos patienter med urothelial carcinom
29. april 2021 opdateret af: Hellenic Cooperative Oncology Group
Undersøgelse af prognostiske biomarkører hos patienter med urothelial carcinom behandlet med platinregimer
Blærekræft (BC) er en heterogen malignitet med dystert udfald. På trods af behandling er de 5-årige samlede overlevelsesrater for MIBC <50 %, med mange patienter, der ikke reagerer eller er ude af stand, hvilket nødvendiggør biomarkører for at udvælge dem, der er mest tilbøjelige til at reagere eller egnede til behandling
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
I denne undersøgelse blev associationerne mellem de hyppigst muterede gener og med klinikopatologiske træk vurderet, såvel som den prognostiske betydning af tilstedeværelsen af mutationer i de øverste muterede og DNA Damage Response (DDR) muterede gener i form af Overall Survival (OS).
Desuden blev den samlede tæthed af tumorinfiltrerende lymfocytter (TIL'er) målt, analyseret immunhistokemisk ekspressionen af PD-L1, de fire MMR-proteiner (MLH1, MSH2, MSH6 og PMS2) og tumor- eller stromale CD8+ cytotoksiske T-lymfocytinfiltrater og vurderet deres sammenhæng med hinanden, topmuterede gener og tilgængelige klinisk-patologiske parametre sammen med deres rolle i prognosen.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
66
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Dette er en transnational analyse med bioprøver fra patienter med urothelial carcinom behandlet med platin-regimer.
Patienter er blevet behandlet i Hellenic Cooperative Oncology Group (HeCOG) tilknyttede onkologiske afdelinger.
Beskrivelse
Inklusionskriterier:
- Urothelial carcinom lokaliseret i blæren
- Patienter behandlet med platinregimer med neoadjuvans. adjuvant indstilling
- Skriftligt informeret samtykke til brug af biologisk materiale
Ekskluderingskriterier:
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Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Vurdering af mutationsprofil hos patienter med urothelial carcinom
Tidsramme: Op til 5 år
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Op til 5 år
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Association af mutationsprofil med PD-L1-ekspression
Tidsramme: Op til 5 år
|
Op til 5 år
|
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Sammenslutning af den prognostiske betydning af mutationer med hensyn til den samlede overlevelse
Tidsramme: Op til 5 år
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Op til 5 år
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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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 (Faktiske)
1. maj 2000
Primær færdiggørelse (Faktiske)
1. marts 2017
Studieafslutning (Faktiske)
1. juni 2017
Datoer for studieregistrering
Først indsendt
29. april 2021
Først indsendt, der opfyldte QC-kriterier
29. april 2021
Først opslået (Faktiske)
4. maj 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. maj 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Biomarkers_Urothelial
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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