Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03051191 |
| Other study ID # |
SHIP02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2017 |
| Est. completion date |
December 1, 2019 |
Study information
| Verified date |
February 2017 |
| Source |
Sakakibara Heart Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
