CancerSHIP-CSNCT03005834
The Sakakibara Health Integrative Profile Cohort Study
An observational study of Cancer, run by Sakakibara Heart Institute.
Trial summary
Because of the genetic and traditional commonalities between the underlying causes of atherosclerotic cardiovascular diseases (CVD) and cancers, we hypothesized that patients with atherosclerotic CVD may have a high incidence of cancers when compared with those with non-atherosclerotic CVD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- incidence of cancers
- How many people
- 32,095 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Jul 2014
- How long will I take part?
- 1020 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: A total of 36,151 patients (58% male, 61±23 years) with any cardiovascular diseases (CVD) enrolled in the SHIP cohort study between June 2006 and July 2014.
Who may be able to join
- Among a total of 36,151 patients with any CVD enrolled in the SHIP cohort study between June 2006 and July 2014, we analyzed a total of 32,095 consecutive patients with acquired CVD in the present study after excluding 4,056 patients with known cancers and/or congenital CVD.
Who cannot join
- We excluded 245 patients who had already been diagnosed with any cancers at the time of enrollment in the SHIP cohort study, and 3,811 patients with congenital CVD including Marfan syndrome.
About this study
Official title: Incidence of Cancers in Patients With Atherosclerotic Cardiovascular Diseases
Because of the genetic and traditional commonalities between the underlying causes of atherosclerotic cardiovascular diseases (CVD) and cancers, we hypothesized that patients with atherosclerotic CVD may have a high incidence of cancers when compared with those with non-atherosclerotic CVD. To address this hypothesis, we investigated longitudinal clinical outcomes in a total of 32,095 consecutive patients with CVD enrolled in the Sakakibara Health Integrative Profile (SHIP) cohort study which was launched in 2006 for the purpose of improving healthy life expectancy in patients with CVD in our institute.
Read the detailed description
The SHIP cohort study was launched in 2006 for the purpose of improving healthy life expectancy in patients with any cardiovascular diseases (CVD) who were admitted to the Sakakibara Heart Institute. The study used a continuous surveillance system to track all subsequent incidents of CVD and/or non-CVD including cancers, via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year. Organ sites of cancers were also identified whenever possible. The study sorted any diagnoses of CVD into nine categories, namely coronary artery diseases, aortic diseases, peripheral artery diseases, myocardial diseases, unclassified or any-cause heart failure, valvular heart diseases, arrhythmias, congenital CVD, and others. For example, if a patient had a couple of diseases, he or she had a plural category. Cerebrovascular diseases were included in the category of 'others' because of the mixed cause for the diseases such as embolic strokes, lacunar infarction, cardio-embolic strokes, and hemorrhagic strokes, etc. Atherosclerotic CVD were defined by the presence of one or more of the following three diseases: coronary artery diseases, aortic diseases and peripheral artery diseases. With regard to the detail of coronary artery diseases, there were acute coronary syndromes, previous myocardial infarction and stable ischemic heart diseases. Aortic diseases consisted of acute aortic syndromes and aortic aneurysms. Non-atherosclerotic CVD were defined as any CVD except atherosclerotic and congenital CVD. The SHIP cohort study also handled to define lifestyle related diseases when confirmed a diagnosis of one or more of the presence of hypertension, dyslipidemia, diabetes mellitus and chronic kidney disease in accordance with the universal criteria. A history of tobacco smoking was also identified. Among a total of 36,151 patients with any CVD enrolled in the SHIP cohort study between June 2006 and July 2014, we excluded 245 patients who had already been diagnosed with any cancers at the time of enrollment in the SHIP cohort study, and 3,811 patients with congenital CVD including Marfan syndrome. Thus, we analyzed a total of 32,095 consecutive patients with acquired CVD in the present study.Our study was conducted in two steps to assess an incidence of cancers in patients with acquired CVD. The first step consisted of a comparison between those with atherosclerotic CVD and non-atherosclerotic CVD with regard to an incidence of cancers. The second step determined the association between a singular presence versus a plural presence of atherosclerotic CVD and an incidence of cancers.
- Conditions
- Cancer
- Being tested
- incidence of cancers
- Keywords
- Atherosclerotic cardiovascular diseases, cancers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incidence of cancersOther
With a continuous surveillance system to track all subsequent incidents of CVD and/or non-CVD 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 |
|---|---|---|
| Atherosclerotic CVD | Atherosclerotic cardiovascular diseases (CVD) included coronary artery diseases, aortic diseases and peripheral artery diseases. Receives: Other: incidence of cancers | |
| Non-atherosclerotic CVD | Non-atherosclerotic cardiovascular diseases (CVD) were any CVD except atherosclerotic CVD and congenital CVD. Receives: Other: incidence of cancers |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of cancers
Measured: July, 2014
Secondary outcomes (1)
any cause mortality
Measured: July, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJun 2006
- Primary completionJul 2014
- Study completionJul 2014
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 CancerStudies 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
- 32,095 participants (actual)
- Target duration
- 1020 Days
Sponsor and investigators
- Lead sponsor
- Sakakibara Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Suzuki, Sakakibara Heart Institute
- Investigators
- Makoto Suzuki, MD, Principal investigator, Sakakibara Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005834
- Sponsor's protocol ID
- SHIP01
- Acronym
- SHIP-CS
- Status last verified
- Dec 2016
- First submitted
- 26 Dec 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Suzuki M, Tomoike H, Sumiyoshi T, Nagatomo Y, Hosoda T, Nagayama M, Ishikawa Y, Sawa T, Iimuro S, Yoshikawa T, Hosoda S. Incidence of cancers in patients with atherosclerotic cardiovascular diseases. Int J Cardiol Heart Vasc. 2017 Sep 14;17:11-16. doi: 10.1016/j.ijcha.2017.08.004. eCollection 2017 Dec.
PubMed 28948207
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Cancers in Patients With Atherosclerotic Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT03005834
- Acronym / sponsor ID
- SHIP-CS / SHIP01
- Conditions
- Cancer
- Keywords
- Atherosclerotic cardiovascular diseases, cancers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32,095 participants (actual)
- Lead sponsor
- Sakakibara Heart InstituteUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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.
Because of the genetic and traditional commonalities between the underlying causes of atherosclerotic cardiovascular diseases (CVD) and cancers, we hypothesized that patients with atherosclerotic CVD may have a high incidence of cancers when compared with those with non-atherosclerotic CVD. To address this hypothesis, we investigated longitudinal clinical outcomes in a total of 32,095 consecutive patients with CVD enrolled in the Sakakibara Health Integrative Profile (SHIP) cohort study which was launched in 2006 for the purpose of improving healthy life expectancy in patients with CVD in our institute.
Detailed description
The SHIP cohort study was launched in 2006 for the purpose of improving healthy life expectancy in patients with any cardiovascular diseases (CVD) who were admitted to the Sakakibara Heart Institute. The study used a continuous surveillance system to track all subsequent incidents of CVD and/or non-CVD including cancers, via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year. Organ sites of cancers were also identified whenever possible. The study sorted any diagnoses of CVD into nine categories, namely coronary artery diseases, aortic diseases, peripheral artery diseases, myocardial diseases, unclassified or any-cause heart failure, valvular heart diseases, arrhythmias, congenital CVD, and others. For example, if a patient had a couple of diseases, he or she had a plural category. Cerebrovascular diseases were included in the category of 'others' because of the mixed cause for the diseases such as embolic strokes, lacunar infarction, cardio-embolic strokes, and hemorrhagic strokes, etc. Atherosclerotic CVD were defined by the presence of one or more of the following three diseases: coronary artery diseases, aortic diseases and peripheral artery diseases. With regard to the detail of coronary artery diseases, there were acute coronary syndromes, previous myocardial infarction and stable ischemic heart diseases. Aortic diseases consisted of acute aortic syndromes and aortic aneurysms. Non-atherosclerotic CVD were defined as any CVD except atherosclerotic and congenital CVD. The SHIP cohort study also handled to define lifestyle related diseases when confirmed a diagnosis of one or more of the presence of hypertension, dyslipidemia, diabetes mellitus and chronic kidney disease in accordance with the universal criteria. A history of tobacco smoking was also identified. Among a total of 36,151 patients with any CVD enrolled in the SHIP cohort study between June 2006 and July 2014, we excluded 245 patients who had already been diagnosed with any cancers at the time of enrollment in the SHIP cohort study, and 3,811 patients with congenital CVD including Marfan syndrome. Thus, we analyzed a total of 32,095 consecutive patients with acquired CVD in the present study.Our study was conducted in two steps to assess an incidence of cancers in patients with acquired CVD. The first step consisted of a comparison between those with atherosclerotic CVD and non-atherosclerotic CVD with regard to an incidence of cancers. The second step determined the association between a singular presence versus a plural presence of atherosclerotic CVD and an incidence of cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1020 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atherosclerotic CVD | – | Other: incidence of cancersAtherosclerotic cardiovascular diseases (CVD) included coronary artery diseases, aortic diseases and peripheral artery diseases. |
| Non-atherosclerotic CVD | – | Other: incidence of cancersNon-atherosclerotic cardiovascular diseases (CVD) were any CVD except atherosclerotic CVD and congenital CVD. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 36,151 patients (58% male, 61±23 years) with any cardiovascular diseases (CVD) enrolled in the SHIP cohort study between June 2006 and July 2014.
Key inclusion criteria (1 listed)
- Among a total of 36,151 patients with any CVD enrolled in the SHIP cohort study between June 2006 and July 2014, we analyzed a total of 32,095 consecutive patients with acquired CVD in the present study after excluding 4,056 patients with known cancers and/or congenital CVD.
Key exclusion criteria (1 listed)
- We excluded 245 patients who had already been diagnosed with any cancers at the time of enrollment in the SHIP cohort study, and 3,811 patients with congenital CVD including Marfan syndrome.
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 |
|---|---|---|
| incidence of cancersWith a continuous surveillance system to track all subsequent incidents of CVD and/or non-CVD 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 | Atherosclerotic CVD, Non-atherosclerotic CVD |
Primary outcome
incidence of cancers
Time frame: July, 2014
1 secondary outcome
any cause mortality
Time frame: July, 2014
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 30 Dec 2016.
- Derived from this study: PubMed 28948207Suzuki M, Tomoike H, Sumiyoshi T, Nagatomo Y, Hosoda T, Nagayama M, Ishikawa Y, Sawa T, Iimuro S, Yoshikawa T, Hosoda S. Incidence of cancers in patients with atherosclerotic cardiovascular diseases. Int J Cardiol Heart Vasc. 2017 Sep 14;17:11-16. doi: 10.1016/j.ijcha.2017.08.004. eCollection 2017 Dec.
- 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.
Makoto Suzuki, MD principal investigator
Sakakibara Heart Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, 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 30 Dec 2016. 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?
incidence of cancers (time frame: July, 2014). 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 NCT03005834, 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 30 Dec 2016.