- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03051191
Pathogenic Mechanisms of Cancer and Cardiovascular Diseases
Exploring the Pathogenic Mechanisms Shared by Cancer and Cardiovasuclar Diseases
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Fuchu, Japón, 183-0003
- Sakakibara Heart Institute
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Tokyo, Japón, 135-8550
- The Cancer Institute Hospital for Japanese Foundation for Cancer Research
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
Otros nombres:
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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.
Otros nombres:
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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.
Otros nombres:
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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.
Otros nombres:
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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.
Otros nombres:
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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miRNA
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SHIP02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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