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PathogenesisNCT03051191

Pathogenic Mechanisms of Cancer and Cardiovascular Diseases

An observational study of Pathogenesis and Cardiovascular Diseases, run by Sakakibara Heart Institute at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Pathogenesis, Cardiovascular Diseases, Cancer
What is being tested?
micro RNA
How many people
66 participants
Where
2 sitesJapan
Study dates
1 Jan 2017to 1 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • subjects who have multiple cancers

Trial locations and contacts

2 sites in 1 country.

Japan2 sites
  • Sakakibara Heart Institute

    Fuchū, 183-0003

  • The Cancer Institute Hospital for Japanese Foundation for Cancer Research

    Tokyo, 135-8550

Other trials in Japan

About this study

Official title: 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.

Read the detailed 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.

Being tested
micro RNA
Keywords
atherosclerotic cardiovascular diseases, nonischemic heart failure, cancer
Medical subject headings
Cardiovascular Diseases, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • micro RNADiagnostic test

    Also called cell free DNA, 16S rRNA genes of gut microbiota

    micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.

Study groups in NCT03051191
Study groupRoleWhat they receive
1: No ACVD/NIHF or cancersThe patients who do not have ACVD, NIHF or cancers
Receives: Diagnostic Test: micro RNA
2: Cancers but no ACVD/NIHFThe patients who have cancers but no ACVD/NIHF
Receives: Diagnostic Test: micro RNA
3: ACVD and cancersThe patients who have ACVD and cancers
Receives: Diagnostic Test: micro RNA
4: ACVD but no cancersThe patients who have ACVD but no cancers
Receives: Diagnostic Test: micro RNA
5: NIHF and cancersThe patients who have NIHF and cancers
Receives: Diagnostic Test: micro RNA
6: NIHF but no cancersThe patients who have NIHF but no cancers
Receives: Diagnostic Test: micro RNA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. miRNA

    Expression pattern of miRNA in blood

    Measured: At enrollment

  2. Cell free DNA from host

    Quantity of cell free DNA derived from host in blood

    Measured: At enrollment

  3. Cell free DNA from microbiota

    Expression pattern of cell free DNA distinct from microbiota in blood

    Measured: At enrollment

  4. bacterial composition in stool

    the bacterial composition analyzed by shot gun analysis of 16s rRNA genes in stool

    Measured: At enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2017
  2. Study start1 Jan 2017
  3. Primary completion1 Dec 2019
  4. Study completion1 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03051191
Sponsor's protocol ID
SHIP02
Status last verified
Feb 2017
First submitted
9 Feb 2017
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pathogenesis and Cardiovascular Diseases, run by Sakakibara Heart Institute at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

miRNA (time frame: At enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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