COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pathogenic Mechanisms of Cancer and Cardiovascular Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051191
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Japanese Foundation for Cancer Research
Information provided by (Responsible Party):
Sakakibara Heart Institute

Brief 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.

Condition or disease Intervention/treatment
Pathogenesis Cardiovascular Diseases Cancer Diagnostic Test: micro RNA

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Exploring the Pathogenic Mechanisms Shared by Cancer and Cardiovasuclar Diseases
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1: No ACVD/NIHF or cancers
The patients who do not have ACVD, NIHF or cancers
Diagnostic Test: micro RNA
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Other Names:
  • cell free DNA
  • 16S rRNA genes of gut microbiota

2: Cancers but no ACVD/NIHF
The patients who have cancers but no ACVD/NIHF
Diagnostic Test: micro RNA
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Other Names:
  • cell free DNA
  • 16S rRNA genes of gut microbiota

3: ACVD and cancers
The patients who have ACVD and cancers
Diagnostic Test: micro RNA
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Other Names:
  • cell free DNA
  • 16S rRNA genes of gut microbiota

4: ACVD but no cancers
The patients who have ACVD but no cancers
Diagnostic Test: micro RNA
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Other Names:
  • cell free DNA
  • 16S rRNA genes of gut microbiota

5: NIHF and cancers
The patients who have NIHF and cancers
Diagnostic Test: micro RNA
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Other Names:
  • cell free DNA
  • 16S rRNA genes of gut microbiota

6: NIHF but no cancers
The patients who have NIHF but no cancers
Diagnostic Test: micro RNA
micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
Other Names:
  • cell free DNA
  • 16S rRNA genes of gut microbiota




Primary Outcome Measures :
  1. miRNA [ Time Frame: At enrollment ]
    Expression pattern of miRNA in blood

  2. Cell free DNA from host [ Time Frame: At enrollment ]
    Quantity of cell free DNA derived from host in blood

  3. Cell free DNA from microbiota [ Time Frame: At enrollment ]
    Expression pattern of cell free DNA distinct from microbiota in blood

  4. bacterial composition in stool [ Time Frame: At enrollment ]
    the bacterial composition analyzed by shot gun analysis of 16s rRNA genes in stool


Biospecimen Retention:   Samples With DNA
plasma containing cell free DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects who regularly visit outpatient clinic in Sakakibara Heart Institute or The Cancer Institute Hospital of Japanese Foundation of Cancer Research.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051191


Locations
Layout table for location information
Japan
Sakakibara Heart Institute
Fuchu, Japan, 183-0003
The Cancer Institute Hospital for Japanese Foundation for Cancer Research
Tokyo, Japan, 135-8550
Sponsors and Collaborators
Sakakibara Heart Institute
Japanese Foundation for Cancer Research
Investigators
Layout table for investigator information
Principal Investigator: Tsutomu Yoshikawa Sakakibara Heart Institute
Layout table for additonal information
Responsible Party: Sakakibara Heart Institute
ClinicalTrials.gov Identifier: NCT03051191    
Other Study ID Numbers: SHIP02
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sakakibara Heart Institute:
atherosclerotic cardiovascular diseases
nonischemic heart failure
cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases