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- Ensaio Clínico NCT03051191
Pathogenic Mechanisms of Cancer and Cardiovascular Diseases
Exploring the Pathogenic Mechanisms Shared by Cancer and Cardiovasuclar Diseases
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
It has been reported that subjects with cardiovascular diseases (CVD) have higher incidence of cancers compared with general population. Because of the genetic and traditional commonalities between the underlying causes of CVD and cancers, the investigators hypothesized that shared molecular mechanism play a pivotal role in the pathogenesis of CVD including heart failure (HF) and cancers.
MicroRNAs (miRNAs) are small, single-stranded non-coding RNA sequences of about 18-22 nucleotides that interact with specific target messenger RNAs. They are known to be involved in the various processes including development, homeostasis, cell differentiation, proliferation, apoptosis and various diseases by modulating post-transcriptional and translational processes. Some of miRNAs have been reported to be involved in the pathogenesis of cancers. Cell free DNAs (cfDNA) is extracellular nucleic acids found in cell-free plasma in humans. Elevated level of cfDNA was reported in patients with cancer and CVD. 16S ribosomal RNA (rRNA) genes are distinct in microbiota, which can be utilized to quantify the bacterial DNA in the systemic circulation. 16S rRNA genes are also shown to be elevated in patients with CVD. These findings imply the possibility that translocated microbiota might play pivotal roles in the pathogenesis of CVD and cancers. The quantity and composition of gut microbiota have been shown to be altered in various diseases including obesity, diabetes mellitus, hypertension and CVD. The previous findings from fecal transplantation experiments, which showed the disease phenotype was transferred from one to another subject (animal or human), strongly suggest the possibility that microbiota play some pathogenic roles in those diseases.
To address this hypothesis, the investigators are going to cross-sectionally explore the expression pattern of miRNA and cfDNA and the composition of gut microbiota extensively in patients with or without atherosclerotic CVD (ACVD), non-ischemic HF (NIHF), and cancers. The investigators will recruit the participants from the patients who regularly visit the outpatient clinic in Sakakibara Heart Institute or The Cancer Institute Hospital of Japanese Foundation of Cancer Research. The investigators will recruit the patients without ACVD or NIHF and with/without cancers (Group 1/2), those with ACVD and with/without cancers (Group 3/4), and those with NIHF and with/without cancers (Group 5/6). Their peripheral blood will be drawn and stools will be collected. miRNA in exosome will be extracted from plasma and explored by miRNA microarray. cfDNA pattern will be extensively explored by microarray. By comparing the expression pattern of miRNA and cfDNA, and the composition of gut microbiota by 16s rRNA gene shotgun analysis, the investigators will be seeking to find the molecular mechanisms shared by those diseases.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Fuchu, Japão, 183-0003
- Sakakibara Heart Institute
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Tokyo, Japão, 135-8550
- The Cancer Institute Hospital for Japanese Foundation for Cancer Research
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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:
- subjects who regularly visit outpatient clinic in Sakakibara Heart Institute or The Cancer Institute Hospital of Japanese Foundation of Cancer Research.
Exclusion Criteria:
- subjects who have multiple cancers
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Controle de caso
- Perspectivas de Tempo: Transversal
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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1: No ACVD/NIHF or cancers
The patients who do not have ACVD, NIHF or cancers
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micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Outros nomes:
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2: Cancers but no ACVD/NIHF
The patients who have cancers but no ACVD/NIHF
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micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Outros nomes:
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3: ACVD and cancers
The patients who have ACVD and cancers
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micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Outros nomes:
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4: ACVD but no cancers
The patients who have ACVD but no cancers
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micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Outros nomes:
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5: NIHF and cancers
The patients who have NIHF and cancers
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micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Outros nomes:
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6: NIHF but no cancers
The patients who have NIHF but no cancers
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micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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miRNA
Prazo: At enrollment
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Expression pattern of miRNA in blood
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At enrollment
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Cell free DNA from host
Prazo: At enrollment
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Quantity of cell free DNA derived from host in blood
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At enrollment
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Cell free DNA from microbiota
Prazo: At enrollment
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Expression pattern of cell free DNA distinct from microbiota in blood
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At enrollment
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bacterial composition in stool
Prazo: At enrollment
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the bacterial composition analyzed by shot gun analysis of 16s rRNA genes in stool
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At enrollment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Tsutomu Yoshikawa, Sakakibara Heart Institute
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SHIP02
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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