Biomarcadores Prognósticos em Pacientes com Carcinoma Urotelial
29 de abril de 2021 atualizado por: Hellenic Cooperative Oncology Group
Investigação de Biomarcadores Prognósticos em Pacientes com Carcinoma Urotelial Tratados com Regimes de Platina
O câncer de bexiga (BC) é uma malignidade heterogênea com desfecho sombrio. Apesar do tratamento, as taxas de sobrevida geral em 5 anos para MIBC são <50%, com muitos pacientes sem resposta ou inaptos, necessitando de biomarcadores para selecionar aqueles com maior probabilidade de responder ou se adequar ao tratamento
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
Neste estudo foi avaliada a associação entre os genes mutados com maior frequência e com as características clinicopatológicas, bem como o significado prognóstico da presença de mutações nos principais genes mutados e na resposta a danos no ADN (DDR) em termos de Sobrevivência Global (OS).
Além disso, a densidade geral de linfócitos infiltrantes de tumor (TILs) foi medida, analisada imuno-histoquimicamente a expressão de PD-L1, as quatro proteínas MMR (MLH1, MSH2, MSH6 e PMS2) e infiltrados tumorais ou estromais de linfócitos T citotóxicos CD8+ e avaliada sua associação com entre si, principais genes mutados e parâmetros clínico-patológicos disponíveis, juntamente com seu papel no prognóstico.
Tipo de estudo
Observacional
Inscrição (Real)
66
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Esta é uma análise transnacional com bioamostras de pacientes com carcinoma urotelial tratados com regimes de platina.
Os pacientes foram tratados em departamentos de oncologia afiliados ao Hellenic Cooperative Oncology Group (HeCOG).
Descrição
Critério de inclusão:
- Carcinoma urotelial localizado na bexiga
- Pacientes tratados com esquemas de platina na neoadjuvante. cenário adjuvante
- Consentimento informado por escrito para o uso de material biológico
Critério de exclusão:
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Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Avaliação do perfil mutacional em pacientes com carcinoma urotelial
Prazo: Até 5 anos
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Até 5 anos
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Associação de perfil mutacional com expressão de PD-L1
Prazo: Até 5 anos
|
Até 5 anos
|
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Associação da significância prognóstica das mutações com relação à sobrevida global
Prazo: Até 5 anos
|
Até 5 anos
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de maio de 2000
Conclusão Primária (Real)
1 de março de 2017
Conclusão do estudo (Real)
1 de junho de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
29 de abril de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de abril de 2021
Primeira postagem (Real)
4 de maio de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de maio de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de abril de 2021
Última verificação
1 de abril de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Biomarkers_Urothelial
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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