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Pathogenic Mechanisms of Cancer and Cardiovascular Diseases

19. oktober 2020 opdateret af: Sakakibara Heart Institute

Exploring the Pathogenic Mechanisms Shared by Cancer and Cardiovasuclar Diseases

Subjects with cardiovascular diseases (CVD) have higher incidence of cancers compared to general population. The investigators hypothesized that shared molecular mechanism play a pivotal role in the pathogenesis of CVD including heart failure (HF) and cancers. To address this hypothesis, the investigators are going to explore the expression pattern of micro RNA (miRNA) and cell free DNA (cfDNA) derived from host, gut microbiota and gut microbiota composition extensively in patients with or without CVD, non-ischemic HF (NIHF), and cancers. The participants will be recruited from the outpatient clinic in Sakakibara Heart Institute or Japanese Foundation for Cancer Research. By comparing the expression pattern of miRNA, cfDNA, or gut microbiota composition, the investigators are seeking to find the pathogenic mechanisms shared by those diseases.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

66

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Fuchu, Japan, 183-0003
        • Sakakibara Heart Institute
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital for Japanese Foundation for Cancer Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Subjects who regularly visit outpatient clinic in Sakakibara Heart Institute or The Cancer Institute Hospital of Japanese Foundation of Cancer Research.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
1: No ACVD/NIHF or cancers
The patients who do not have ACVD, NIHF or cancers
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Andre navne:
  • cell free DNA
  • 16S rRNA genes of gut microbiota
2: Cancers but no ACVD/NIHF
The patients who have cancers but no ACVD/NIHF
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Andre navne:
  • cell free DNA
  • 16S rRNA genes of gut microbiota
3: ACVD and cancers
The patients who have ACVD and cancers
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Andre navne:
  • cell free DNA
  • 16S rRNA genes of gut microbiota
4: ACVD but no cancers
The patients who have ACVD but no cancers
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Andre navne:
  • cell free DNA
  • 16S rRNA genes of gut microbiota
5: NIHF and cancers
The patients who have NIHF and cancers
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Andre navne:
  • cell free DNA
  • 16S rRNA genes of gut microbiota
6: NIHF but no cancers
The patients who have NIHF but no cancers
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Andre navne:
  • cell free DNA
  • 16S rRNA genes of gut microbiota

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
miRNA
Tidsramme: At enrollment
Expression pattern of miRNA in blood
At enrollment
Cell free DNA from host
Tidsramme: At enrollment
Quantity of cell free DNA derived from host in blood
At enrollment
Cell free DNA from microbiota
Tidsramme: At enrollment
Expression pattern of cell free DNA distinct from microbiota in blood
At enrollment
bacterial composition in stool
Tidsramme: At enrollment
the bacterial composition analyzed by shot gun analysis of 16s rRNA genes in stool
At enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Tsutomu Yoshikawa, Sakakibara Heart Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2017

Primær færdiggørelse (Faktiske)

1. december 2019

Studieafslutning (Faktiske)

1. december 2019

Datoer for studieregistrering

Først indsendt

9. februar 2017

Først indsendt, der opfyldte QC-kriterier

9. februar 2017

Først opslået (Faktiske)

13. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. oktober 2020

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SHIP02

Plan for individuelle deltagerdata (IPD)

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med micro RNA

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