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.
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
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.
- Conditions
- Pathogenesis, Cardiovascular Diseases, Cancer
- 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 group | Role | What they receive |
|---|---|---|
| 1: No ACVD/NIHF or cancers | The patients who do not have ACVD, NIHF or cancers Receives: Diagnostic Test: micro RNA | |
| 2: Cancers but no ACVD/NIHF | The patients who have cancers but no ACVD/NIHF Receives: Diagnostic Test: micro RNA | |
| 3: ACVD and cancers | The patients who have ACVD and cancers Receives: Diagnostic Test: micro RNA | |
| 4: ACVD but no cancers | The patients who have ACVD but no cancers Receives: Diagnostic Test: micro RNA | |
| 5: NIHF and cancers | The patients who have NIHF and cancers Receives: Diagnostic Test: micro RNA | |
| 6: NIHF but no cancers | The 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.
miRNA
Expression pattern of miRNA in blood
Measured: At enrollment
Cell free DNA from host
Quantity of cell free DNA derived from host in blood
Measured: At enrollment
Cell free DNA from microbiota
Expression pattern of cell free DNA distinct from microbiota in blood
Measured: At enrollment
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.
- First posted13 Feb 2017
- Study start1 Jan 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PathogenesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sakakibara Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Japanese Foundation for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Tsutomu Yoshikawa, Principal investigator, Sakakibara Heart Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Pathogenic Mechanisms Shared by Cancer and Cardiovasuclar Diseases
- ClinicalTrials.gov ID
- NCT03051191
- Acronym / sponsor ID
- SHIP02
- Conditions
- Pathogenesis, Cardiovascular Diseases, Cancer
- Keywords
- atherosclerotic cardiovascular diseases, nonischemic heart failure, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sakakibara Heart InstituteUniversity, hospital or other
- Collaborators
- Japanese Foundation for Cancer Research
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1: No ACVD/NIHF or cancers | – | Diagnostic Test: micro RNAThe patients who do not have ACVD, NIHF or cancers |
| 2: Cancers but no ACVD/NIHF | – | Diagnostic Test: micro RNAThe patients who have cancers but no ACVD/NIHF |
| 3: ACVD and cancers | – | Diagnostic Test: micro RNAThe patients who have ACVD and cancers |
| 4: ACVD but no cancers | – | Diagnostic Test: micro RNAThe patients who have ACVD but no cancers |
| 5: NIHF and cancers | – | Diagnostic Test: micro RNAThe patients who have NIHF and cancers |
| 6: NIHF but no cancers | – | Diagnostic Test: micro RNAThe patients who have NIHF but no cancers |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- subjects who regularly visit outpatient clinic in Sakakibara Heart Institute or The Cancer Institute Hospital of Japanese Foundation of Cancer Research.
Key exclusion criteria (1 listed)
- subjects who have multiple cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micro RNAAlso: cell free DNA, 16S rRNA genes of gut microbiotamicro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment. | Diagnostic test | 1: No ACVD/NIHF or cancers, 2: Cancers but no ACVD/NIHF, 3: ACVD and cancers, 4: ACVD but no cancers, 5: NIHF and cancers, 6: NIHF but no cancers |
Primary outcome
miRNA
Time frame: At enrollment
Expression pattern of miRNA in blood
Cell free DNA from host
Time frame: At enrollment
Quantity of cell free DNA derived from host in blood
Cell free DNA from microbiota
Time frame: At enrollment
Expression pattern of cell free DNA distinct from microbiota in blood
bacterial composition in stool
Time frame: At enrollment
the bacterial composition analyzed by shot gun analysis of 16s rRNA genes in stool
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsutomu Yoshikawa principal investigator
Sakakibara Heart Institute
2 sites in 1 country: see every site and its status.
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.