- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03051191
Pathogenic Mechanisms of Cancer and Cardiovascular Diseases
Exploring the Pathogenic Mechanisms Shared by Cancer and Cardiovasuclar Diseases
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Fuchu, Japan, 183-0003
- Sakakibara Heart Institute
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Tokyo, Japan, 135-8550
- The Cancer Institute Hospital for Japanese Foundation for Cancer Research
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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 navn:
|
|
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 navn:
|
|
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 navn:
|
|
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 navn:
|
|
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 navn:
|
|
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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
miRNA
Tidsramme: At enrollment
|
Expression pattern of miRNA in blood
|
At enrollment
|
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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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Tsutomu Yoshikawa, Sakakibara Heart Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SHIP02
Plan for individuelle deltakerdata (IPD)
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