CancersSHIP-ACNCT04198896
The Sakakibara Health Integrative Profile of Atherosclerotic-Carcinogenesis Hypothesis (SHIP-AC)
An observational study of Cancers and Atheroscleroses, Coronary, run by Sakakibara Heart Institute.
Trial summary
As previously reported (IJC Heart \& Vasculature 2017; 17: 11.), our epidemiological analysis showing high incidence of cancers in patients with atherosclerotic cardiovascular diseases as compared with those with non-atherosclerotic cardiovascular diseases may imply a clinical possibility of a role of atherosclerosis… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancers, Atheroscleroses, Coronary, Atherosclerosis of Artery
- What is being tested?
- incidece of cancers
- How many people
- 8,856 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Oct 2019
- How long will I take part?
- 1095 Days
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: same as eligibility criteria
Who may be able to join
- patients with diagnosed coronary artery diseases without a dignosis of cancers at the entry of SHIP between January 2009 and July 2014.
Who cannot join
- patients with diagnosed coronary artery diseases who had already been diagnosed with any cancers at the time of enrollment in the SHIP, and who were not followed-up after the entry of SHIP.
About this study
Official title: Clinical Aspects of Atherosclerotic-Carcinogenesis Hypothesis
As previously reported (IJC Heart \& Vasculature 2017; 17: 11.), our epidemiological analysis showing high incidence of cancers in patients with atherosclerotic cardiovascular diseases as compared with those with non-atherosclerotic cardiovascular diseases may imply a clinical possibility of a role of atherosclerosis in cancer developments. In the present study, to address our hypothesis that cancer developments may come with a strength of atherosclerosis, we traced an incidence of cancers in a total of 8,856 patients with coronary artery diseases (CAD) for a median follow-up of 1,095 days (interquartile range, 719-1,469 days) using the Sakakibara Health Integrative Profile (SHIP) database.
Read the detailed description
In accordance with a presence or absence of poly-arterial diseases such as aortic and/or peripheral artery diseases as an indicator of a strength of atherosclerosis, an incidence of cancers and all-cause death in two cohorts of 8,140 patients with CAD-only and 716 with CAD with poly-arterial diseases were evaluated to track an incidence of cancers and ali-cause mortality during median follou-up periods of 3 to 4 years.
- Being tested
- incidece of cancers
- Keywords
- Atherosclerosis, cancers
- Medical subject headings
- Neoplasms, Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incidece of cancersOther
With a continuous surveillance system to track all subsequent incidents of cardiovascular diseases and/or non-cardiovascular diseases via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year, an incidence of cancers was identified
| Study group | Role | What they receive |
|---|---|---|
| CAD-only | patients with diagnosed coronary artery diseases (CAD) without any other atherosclerotic cardiovascuar diseases at the entry of SHIP Receives: Other: incidece of cancers | |
| CAD with poly-arterial diseases | patients with diagnosed coronary artery diseases (CAD) with other atherosclerotic cardiovascuar diseases such as any of aortic and/or peripheral artery diseases at the entry of SHIP Receives: Other: incidece of cancers |
What is being measured
The primary outcome is the main question the study is designed to answer.
inicidence of cancers
number of all types of cancers during follow-up periods
Measured: through study completion, an average of 3 years
Secondary outcomes (1)
all-cause mortality
number of all types of death during follow-up periods
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study startJan 2009
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,856 participants (actual)
- Target duration
- 1095 Days
Sponsor and investigators
- Lead sponsor
- Sakakibara Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Suzuki, Sakakibara Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198896
- Sponsor's protocol ID
- SHIP03
- Acronym
- SHIP-AC
- Status last verified
- Dec 2019
- First submitted
- 8 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After completed, the data will be shared with simlar study investigators over the world
Publications
Suzuki M, Tomoike H, Dai Z, Hosoda T, Sumiyoshi T, Hosoda S, Isobe M. Polyvascular Disease and the Incidence of Cancer in Patients with Coronary Artery Disease. JMA J. 2022 Oct 17;5(4):498-509. doi: 10.31662/jmaj.2022-0098. Epub 2022 Sep 26.
PubMed 36407071
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Aspects of Atherosclerotic-Carcinogenesis Hypothesis
- ClinicalTrials.gov ID
- NCT04198896
- Acronym / sponsor ID
- SHIP-AC / SHIP03
- Keywords
- Atherosclerosis, cancers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,856 participants (actual)
- Lead sponsor
- Sakakibara Heart InstituteUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 13 Dec 2019 (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.
As previously reported (IJC Heart \& Vasculature 2017; 17: 11.), our epidemiological analysis showing high incidence of cancers in patients with atherosclerotic cardiovascular diseases as compared with those with non-atherosclerotic cardiovascular diseases may imply a clinical possibility of a role of atherosclerosis in cancer developments. In the present study, to address our hypothesis that cancer developments may come with a strength of atherosclerosis, we traced an incidence of cancers in a total of 8,856 patients with coronary artery diseases (CAD) for a median follow-up of 1,095 days (interquartile range, 719-1,469 days) using the Sakakibara Health Integrative Profile (SHIP) database.
Detailed description
In accordance with a presence or absence of poly-arterial diseases such as aortic and/or peripheral artery diseases as an indicator of a strength of atherosclerosis, an incidence of cancers and all-cause death in two cohorts of 8,140 patients with CAD-only and 716 with CAD with poly-arterial diseases were evaluated to track an incidence of cancers and ali-cause mortality during median follou-up periods of 3 to 4 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1095 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD-only | – | Other: incidece of cancerspatients with diagnosed coronary artery diseases (CAD) without any other atherosclerotic cardiovascuar diseases at the entry of SHIP |
| CAD with poly-arterial diseases | – | Other: incidece of cancerspatients with diagnosed coronary artery diseases (CAD) with other atherosclerotic cardiovascuar diseases such as any of aortic and/or peripheral artery diseases at the entry of SHIP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- same as eligibility criteria
Key inclusion criteria (1 listed)
- patients with diagnosed coronary artery diseases without a dignosis of cancers at the entry of SHIP between January 2009 and July 2014.
Key exclusion criteria (1 listed)
- patients with diagnosed coronary artery diseases who had already been diagnosed with any cancers at the time of enrollment in the SHIP, and who were not followed-up after the entry of SHIP.
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 |
|---|---|---|
| incidece of cancersWith a continuous surveillance system to track all subsequent incidents of cardiovascular diseases and/or non-cardiovascular diseases via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year, an incidence of cancers was identified | Other | CAD with poly-arterial diseases, CAD-only |
Primary outcome
inicidence of cancers
Time frame: through study completion, an average of 3 years
number of all types of cancers during follow-up periods
1 secondary outcome
all-cause mortality
Time frame: through study completion, an average of 3 years
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 18 Dec 2019.
- Derived from this study: PubMed 36407071Suzuki M, Tomoike H, Dai Z, Hosoda T, Sumiyoshi T, Hosoda S, Isobe M. Polyvascular Disease and the Incidence of Cancer in Patients with Coronary Artery Disease. JMA J. 2022 Oct 17;5(4):498-509. doi: 10.31662/jmaj.2022-0098. Epub 2022 Sep 26.
- Individual participant dataSharing planned: No. After completed, the data will be shared with simlar study investigators over the world
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancers and Atheroscleroses, Coronary, run by Sakakibara Heart Institute.
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 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
inicidence of cancers (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04198896, which also lists 1 linked publication.
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 18 Dec 2019.