- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01231386
MIRNA Profiling of Breast Cancer in Patients Undergoing Neoadjuvant or Adjuvant Treatment for Locally Advanced & Inflammatory Breast Cancer
Visão geral do estudo
Status
Condições
Descrição detalhada
Current neoadjuvant or adjuvant treatment strategies do not allow for rationale incorporation of such agents. One needs tools to predict both de novo and acquired resistance to therapeutic agents. This is a difficult task, due to the compound nature of escape routes: tumor exposure is usually to a combination of therapeutic agents and the mechanisms of resistance are broad: intrinsic resistance due to existing mutations, or regulatory - miRNA, other epigenetic - alterations, polymorphisms, tumor cell adaptation via new mutations and activation of alternative pathways, lack of optimal pharmacokinetics/genomics, activation of efflux mechanisms, accelerated repair mechanisms are involved.
Similarly, not all patients who are candidates for primary surgical intervention to be followed by post-operative adjuvant therapy benefit from such systemic treatments. The mechanisms of resistance be it de novo in surviving stem cell/tumorigenic components, or acquired by cells left behind "dormant" after the surgical intervention, are not well delineated.
Breast tumors subjected to neoadjuvant chemotherapy allow for baseline and treatment-effected sampling. Characterization of core biopsy specimens of primary tumors procured prior to exposure to neoadjuvant therapy from different varieties of breast cancer subtypes, and of subsequent mid-treatment and intraoperative (procured during definitive surgery following completion of neoadjuvant therapy) samples should help to assess the predictive value of the pre-treatment and post-treatment miRNA expression profile for complete and near complete response, as a surrogate marker for survival. Similarly, patterns of de novo and acquired resistance may emerge when assessment of pre- and post treatment miRNA expression profiles are analyzed in a supervised manner of classification using pathological response as classifier. Samples obtained from patients with primary surgical removal of their tumors before any systemic treatment exposure on the other hand, will allow for determining markers of prognosis, and predictors for response to therapeutic targeting agents.
Time Perspective: Retrospective/Prospective
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
California
-
Duarte, California, Estados Unidos, 91010
- City of Hope
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Female,
- Breast Cancer
- > 18 years,
- regardless of histology, treatment phase, or stage
Exclusion Criteria:
-
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Performance of miRNA profiling from tumor samples from primary breast tumors
Prazo: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
Assessment of miRNA profiles from blood/serum samples from patients at baseline, and if feasible, at different time points
Prazo: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
Analysis of miRNA findings and correlate miRNA patterns of expression in tumor, lymph nodes -if available- and in serum
Prazo: 3 years after competion of sample collection
|
3 years after competion of sample collection
|
Correlation of classic tumor markers such as estrogen and progesterone receptor (ER,PR), and HER2 expression with tumor stage and grade
Prazo: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
Determination of specific miRNA functions
Prazo: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
Determination of ability to knock down functionally relevant overexpressed miRNAs by miR-sponge/antagomirs
Prazo: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
Design of prospective pilot phase I-II trials to interfere with dysfunctional/dysregulated miRNA expression
Prazo: 3 years after completion of sample collection
|
3 years after completion of sample collection
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: George Somlo, MD, City of Hope Medical Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 09147
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 .
Ensaios clínicos em Câncer de mama
-
Turku University HospitalLounais-Suomen SyöpäyhdistysAinda não está recrutandoSobrevivente de cancerFinlândia
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RetiradoSobrevivente de cancerEstados Unidos
-
University of Alabama at BirminghamNational Cancer Institute (NCI); Auburn UniversityConcluído
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos, Guam
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); National Institute of Mental Health (NIMH)ConcluídoSobrevivente de cancerEstados Unidos
-
Masonic Cancer Center, University of MinnesotaConcluídoSobrevivente de cancerEstados Unidos
-
University of New MexicoNew Mexico State University; University of New Mexico Cancer CenterConcluído
-
Ohio State University Comprehensive Cancer CenterConcluídoSobrevivente de cancerEstados Unidos
-
Abramson Cancer Center of the University of PennsylvaniaConcluídoPlano de cuidados de sobrevivência LIVESTRONG: coleta contínua de dados e pesquisa de acompanhamentoPaciente com cancerEstados Unidos