UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035118 |
|---|---|
| Receipt number | R000039991 |
| Scientific Title | Suicide, other externally caused injuries, and cardiovascular death following a cancer diagnosis: a nationwide population-based study in Japan |
| Date of disclosure of the study information | 2018/12/03 |
| Last modified on | 2023/08/30 09:35:43 |
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Basic information
Public title
Suicide, other externally caused injuries, and cardiovascular death following a cancer diagnosis: a nationwide population-based study in Japan
Acronym
Suicide and cardiovascular death following a cancer diagnosis: a nationwide study in Japan
Scientific Title
Suicide, other externally caused injuries, and cardiovascular death following a cancer diagnosis: a nationwide population-based study in Japan
Scientific Title:Acronym
Suicide and cardiovascular death following a cancer diagnosis: a nationwide study in Japan
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general | Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We compare the risk of suicide, other externally caused injuries, and cardiovascular death during 5 year following a cancer diagnosis with that of the general population, using the National Cancer Registry in Japan.
Basic objectives2
Others
Basic objectives -Others
We will also aim at identifying higher risk patients and time period of suicide, other externally caused injuries, and cardiovascular death following a cancer diagnosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Standardized mortality ratios (SMRs) and excess absolute risks (EARs) for suicide, other externally caused injuries, and cardiovascular death following a cancer diagnosis
Key secondary outcomes
SMRs and EARs will be calculated separately in relation to a number of factors: sex, age at diagnosis, time since cancer diagnosis, prefecture, primary tumor site, behavioral code in the ICD-O-3, tumor extent, presence/absence of the definitive surgery, and month of death.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Our study cohort will consist of all cancer cases, diagnosed in Japan from January 1, 2016 to December 31, 2022 and registered in the NCR.
Key exclusion criteria
(1)cancer cases diagnosed at autopsy incidentally
(2)cancer cases reported on death certificate only
(3)cancer cases with missing information on diagnosis date
Target sample size
7000000
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Fujimori |
Organization
National Cancer Center Institute for Cancer Control
Division name
Division of Survivorship Research
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3547-5201
mfujimor@ncc.go.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Harashima |
Organization
National Cancer Center Institute for Cancer Control
Division name
Division of Survivorship Research
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3547-5201
Homepage URL
sharashi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Japan
Institute
Department
Personal name
Funding Source
Organization
the Health Labor Sciences Research Grant and the Innovative Research Program on Suicide Countermeasures.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
institutional review board and ethics committee of the National Cancer Center Japan
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/9/7/e030681.long
Publication of results
Partially published
Result
URL related to results and publications
https://academic.oup.com/jjco/article/51/5/744/6126762
Number of participants that the trial has enrolled
546148
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 02 | Month | 03 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Our study cohort will consist of all cancer cases, diagnosed from January 1, 2016 to December 31, 2022 in Japan and registered in the NCR and they will be followed up until 5 years after cancer diagnosis. We will identify cancer patients who died from suicide, ECIs, and cardiovascular causes based on cause of death registered in the NCR database. Outcomes will be classified according to the ICD-10 as follows: suicide (X60-X84 and Y87.0), other ECIs (V01-X59 and Y10-Y34), and cardiovascular diseases (I00-I99). We will calculate standardized mortality ratios (SMRs) and excess absolute risks (EARs) for suicide, other ECIs, and cardiovascular death in comparison with the general population in Japan, after adjustment for sex, age, and prefectures. SMRs and EARs will be calculated separately in relation to a number of factors: sex, age at diagnosis, time since cancer diagnosis, prefecture of residence at diagnosis, primary tumor site, behavioral code in the ICD-O-3, tumor extent, whether definitive surgery to the primary site was performed, and month of death.
We will also explore the suicide methods used by cancer patients and factors affecting choice of their suicide methods. We will also divide cancer patients who died during observation period into three groups according to main cause of death and compare characteristics of patients and tumors between each group: those whose main cause of death are cancer, those whose main cause are suicide, other ECIs, and cardiovascular diseases, and those with the other main cause of death.
Management information
Registered date
| 2018 | Year | 12 | Month | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039991
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