Prognostiske biomarkører hos pasienter med urotelialt karsinom
29. april 2021 oppdatert av: Hellenic Cooperative Oncology Group
Undersøkelse av prognostiske biomarkører hos pasienter med urothelial karsinom behandlet med platinaregimer
Blærekreft (BC) er en heterogen malignitet med et dystert resultat. Til tross for behandling er den totale 5-års overlevelsesraten for MIBC <50 %, med mange pasienter som ikke reagerer eller er inkompetente, noe som krever biomarkører for å velge de som mest sannsynlig vil respondere eller passe for behandling
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
I denne studien ble assosiasjonene mellom de hyppigst muterte gener og med klinikopatologiske egenskaper vurdert, så vel som den prognostiske betydningen av tilstedeværelsen av mutasjoner i de toppmuterte og DNA Damage Response (DDR) muterte genene når det gjelder total overlevelse (OS).
Dessuten ble total tetthet av tumorinfiltrerende lymfocytter (TILs) målt, analysert immunhistokjemisk ekspresjonen av PD-L1, de fire MMR-proteinene (MLH1, MSH2, MSH6 og PMS2) og tumor- eller stromale CD8+ cytotoksiske T-lymfocyttinfiltrater og vurdert deres assosiasjon med hverandre, topp muterte gener og tilgjengelige klinikopatologiske parametere sammen med deres rolle i prognose.
Studietype
Observasjonsmessig
Registrering (Faktiske)
66
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Dette er en transnasjonal analyse med bioprøver fra pasienter med urotelialt karsinom behandlet med platinaregimer.
Pasienter har blitt behandlet i Hellenic Cooperative Oncology Group (HeCOG) tilknyttede avdelinger for onkologi.
Beskrivelse
Inklusjonskriterier:
- Urothelial karsinom lokalisert i blæren
- Pasienter behandlet med platinaregimer med neoadjuvans. adjuvant setting
- Skriftlig informert samtykke til bruk av biologisk materiale
Ekskluderingskriterier:
-
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Vurdering av mutasjonsprofil hos pasienter med urotelialt karsinom
Tidsramme: Inntil 5 år
|
Inntil 5 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assosiasjon av mutasjonsprofil med PD-L1-ekspresjon
Tidsramme: Inntil 5 år
|
Inntil 5 år
|
|
Forening av den prognostiske betydningen av mutasjoner med hensyn til total overlevelse
Tidsramme: Inntil 5 år
|
Inntil 5 år
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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- Huang HS, Su HY, Li PH, Chiang PH, Huang CH, Chen CH, Hsieh MC. Prognostic impact of tumor infiltrating lymphocytes on patients with metastatic urothelial carcinoma receiving platinum based chemotherapy. Sci Rep. 2018 May 10;8(1):7485. doi: 10.1038/s41598-018-25944-1.
- Yu A, Mansure JJ, Solanki S, Siemens DR, Koti M, Dias ABT, Burnier MM, Brimo F, Kassouf W. Presence of lymphocytic infiltrate cytotoxic T lymphocyte CD3+, CD8+, and immunoscore as prognostic marker in patients after radical cystectomy. PLoS One. 2018 Oct 11;13(10):e0205746. doi: 10.1371/journal.pone.0205746. eCollection 2018.
- Zhang S, Wang J, Zhang X, Zhou F. Tumor-infiltrating CD8+ lymphocytes predict different clinical outcomes in organ- and non-organ-confined urothelial carcinoma of the bladder following radical cystectomy. PeerJ. 2017 Oct 13;5:e3921. doi: 10.7717/peerj.3921. eCollection 2017.
- Kim HS, Ku JH. Prognostic impact of tumor infiltrating lymphocytes in bladder urothelial carcinoma. Transl Androl Urol. 2019 Jul;8(Suppl 3):S291-S292. doi: 10.21037/tau.2019.04.02. No abstract available.
- Liu H, Ye T, Yang X, Lv P, Wu X, Zhou H, Lu H, Tang K, Ye Z. Predictive and Prognostic Role of PD-L1 in Urothelial Carcinoma Patients with Anti-PD-1/PD-L1 Therapy: A Systematic Review and Meta-Analysis. Dis Markers. 2020 Jun 27;2020:8375348. doi: 10.1155/2020/8375348. eCollection 2020.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2000
Primær fullføring (Faktiske)
1. mars 2017
Studiet fullført (Faktiske)
1. juni 2017
Datoer for studieregistrering
Først innsendt
29. april 2021
Først innsendt som oppfylte QC-kriteriene
29. april 2021
Først lagt ut (Faktiske)
4. mai 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. mai 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Biomarkers_Urothelial
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .