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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035118
Receipt No. R000039991
Official scientific title of the study 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 2018/12/05

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Basic information
Official scientific title of the study Suicide, other externally caused injuries, and cardiovascular death following a cancer diagnosis: a nationwide population-based study in Japan
Title of the study (Brief title) 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 the first 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 from 1 January 1, 2016 to 30 June 30, 2016 in Japan 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 500000

Research contact person
Name of lead principal investigator Tatsuo Akechi
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry and Cognitive-Behavioral Medicine
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL 052-853-8271
Email takechi@med.nagoya-cu.ac.jp

Public contact
Name of contact person Saki Harashima
Organization National Cancer Center Japan
Division name Division of Health Care Research, Behavioral Science and Survivorship Research Group, Center for Pub
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3547-5201
Homepage URL
Email sharashi@ncc.go.jp

Sponsor
Institute National Cancer Center Japan
Institute
Department

Funding Source
Organization This work is supported by The Innovative Research Program on Suicide Countermeasures, Japan Support Center for Suicide Countermeasures, National Center of Neurology and Psychiatry.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 29 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Our study cohort will consist of all cancer cases, diagnosed from 1 January, 2016 to 30 June, 2016 in Japan and registered in the NCR. The patients will be observed until death, or 31 December, 2016. 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
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039991

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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