Screening Study for Participants With Malignant Tumors

  • Câncer
  • Tumores Sólidos
Observe que o status de recrutamento do estudo em seu centro pode ser diferente do status geral do estudo porque alguns centros de estudo podem recrutar mais cedo do que outros.
Status do estudo:

Recrutando

Este estudo é realizado em
Cidades
  • Bahia
  • Ceará
  • Minas Gerais
  • Rio de Janeiro
  • Rio Grande do Sul
  • Santa Catarina
  • São Paulo
Identificador de estudo:

NCT05419375 BX43361

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      A seguinte informação vem do site ClinicalTrials.gov publicamente disponível e foi editada para leigos.

      As informações abaixo se origina a partir do site ClinicalTrials.gov publicamente disponível e não foi modificado.

      Results Disclaimer

      Resumo do Estudo

      The study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked Roche clinical trial.

      Hoffmann-La Roche Patrocinador
      Phase 2 Fase
      NCT05419375, BX43361 Identificador de estudo
      Screening platform Tratamento
      Solid Tumors Condição
      Título

      Master Screening Study to Determine Biomarker Status and Potential Trial Eligibility for Patients With Malignant Tumors

      Critérios de elegibilidade

      Todos Gênero
      ≥18 Anos Idade
      Não Voluntários Saudáveis
      Critérios de Inclusão

      General Inclusion Criteria:

      • Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen meeting criteria defined in the protocol
      • Considered by principal investigator (PI) to be a candidate for a linked clinical trial with an investigational medicinal product, and that the participant has the awareness and willingness to participate in said trial

      Inclusion Criteria for Participants with Stage III NSCLC

      • Locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology based on 8th edition of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control (UICC) cancer staging system
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

      Inclusion Criteria for Participants with Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC Requiring Adjuvant Treatment

      • Stage II, IIIA, or select IIIB (T3N2 only) NSCLC based on the 8th edition of the AJCC and UICC cancer staging system (Amin et al. 2017)
      • Considered eligible for curative intent surgery (complete resection with all surgical margins testing negative for tumor)
      • Screening within Study BX43361, using a pretreatment biopsy, is encouraged to be performed as early in the participant treatment pathway as possible to ensure the participant is potentially eligible for all cohorts, and should meet guidelines as defined by the protocol
      • Representative FFPE tumor specimen obtained prior to the start of any treatment
      • ECOG Performance Status of 0 or 1
      Critérios de Exclusão

      General Exclusion Criteria:

      • History of malignancy other than NSCLC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death
      • Any condition that may affect the interpretation of study results
      • Significant liver or cardiovascular disease
      • Prior allogenic stem-cell or solid-organ transplantation

      Sobre Ensaios Clínicos

      O que é um ensaio clinico? Por que devo considerar participar de um estudo clínico? E por que a Roche realiza estudos clínicos?

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