Prognostiska biomarkörer hos patienter med uroteliala karcinom
29 april 2021 uppdaterad av: Hellenic Cooperative Oncology Group
Undersökning av prognostiska biomarkörer hos patienter med uroteliala karcinom som behandlats med platinakurer
Blåscancer (BC) är en heterogen malignitet med ett dystert resultat. Trots behandling är de 5-åriga överlevnaden för MIBC <50 %, med många patienter som inte svarar eller inte fungerar, vilket kräver biomarkörer för att välja ut de som är mest benägna att svara eller lämpa sig för behandling
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
I denna studie bedömdes sambanden mellan de mest frekvent muterade generna och med klinikopatologiska egenskaper, såväl som den prognostiska betydelsen av närvaron av mutationer i de toppmuterade och DNA Damage Response (DDR) muterade generna i termer av total överlevnad (OS).
Dessutom mättes den totala tumörinfiltrerande lymfocyternas (TILs) täthet, analyserades immunhistokemiskt uttrycket av PD-L1, de fyra MMR-proteinerna (MLH1, MSH2, MSH6 och PMS2) och tumör- eller stromala CD8+ cytotoxiska T-lymfocytinfiltrat och bedömde deras samband med varandra, toppmuterade gener och tillgängliga kliniskt patologiska parametrar tillsammans med deras roll i prognos.
Studietyp
Observationell
Inskrivning (Faktisk)
66
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Detta är en transnationell analys med bioprover från patienter med uroteliala karcinom som behandlats med platinabehandlingar.
Patienter har behandlats i Hellenic Cooperative Oncology Group (HeCOG) anslutna avdelningar för onkologi.
Beskrivning
Inklusionskriterier:
- Urothelial carcinom lokaliserad i urinblåsan
- Patienter som behandlades med platinaregimer med neoadjuvans. adjuvant inställning
- Skriftligt informerat samtycke för användning av biologiskt material
Exklusions kriterier:
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Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Bedömning av mutationsprofil hos patienter med urotelial karcinom
Tidsram: Upp till 5 år
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Upp till 5 år
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Association av mutationsprofil med PD-L1-uttryck
Tidsram: Upp till 5 år
|
Upp till 5 år
|
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Samband av den prognostiska betydelsen av mutationer med avseende på total överlevnad
Tidsram: Upp till 5 år
|
Upp till 5 år
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2000
Primärt slutförande (Faktisk)
1 mars 2017
Avslutad studie (Faktisk)
1 juni 2017
Studieregistreringsdatum
Först inskickad
29 april 2021
Först inskickad som uppfyllde QC-kriterierna
29 april 2021
Första postat (Faktisk)
4 maj 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 maj 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 april 2021
Senast verifierad
1 april 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Biomarkers_Urothelial
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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