UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058529 |
|---|---|
| Receipt number | R000066928 |
| Scientific Title | Large Regional Cohort Study of Cancer, Cardiovascular Disease, and Chronic obstructive pulmonary disease from use of heated tobacco products among middle-aged Japanese: A subprotocol from NUHPM1301 UONUMA Cohort Study 2025 |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/20 23:30:38 |
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Basic information
Public title
Large Regional Cohort Study of Cancer, Cardiovascular Disease, and Chronic obstructive pulmonary disease from use of heated tobacco products among middle-aged Japanese: A subprotocol from UONUMA cohort study
Acronym
Large Cohort Study on Health Risk of Heated Tobacco Products
Scientific Title
Large Regional Cohort Study of Cancer, Cardiovascular Disease, and Chronic obstructive pulmonary disease from use of heated tobacco products among middle-aged Japanese: A subprotocol from NUHPM1301 UONUMA Cohort Study 2025
Scientific Title:Acronym
Large Cohort Study on Health Risk of Heated Tobacco Products
Region
| Japan |
Condition
Condition
Cancer, Cardiovascular Disease, Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to investigate the risk of developing cancer, stroke, ischemic heart disease, chronic obstructive pulmonary disease, and lifestyle-related disease caused by the use of heated cigarettes
Basic objectives2
Others
Basic objectives -Others
The secondary objective is to assess whether there is a difference in health risk depending on the style of heated tobacco use (heated tobacco alone, switching from cigarettes to cigarettes, or using both heated and cigarettes).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
New incidence rate of cancers, ischemic heart disease, cerebrovascular disease, COPD, other lifestyle-related diseases, and death events in heated tobacco products users and others
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Of the 34,258 participants in the UONUMA cohort study who were eligible for the 10-year follow-up survey, those who were able to complete the questionnaire.
Key exclusion criteria
Exclusion criteria are withdrawing consent.
Target sample size
34258
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
Division name
Department of Health Promotion Medicine
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo Ward, Niigata City, Japan
TEL
025-368-9009
tomtanak@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Tanaka |
Organization
Niigata University Medical & Dental Hospital
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo Ward, Niigata City, Japan
TEL
025-368-9325
Homepage URL
tomtanak@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Tanaka Tomohiro
Funding Source
Organization
JSPS KAKENHI Grant Number (25K20595)
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
the ethics committee of Niigata University Medical and Dental Hospital
Address
1-754 Asahimachi-dori, Chuo Ward, Niigata City, Japan
Tel
025-227-2625
ethics@adm.niigata-u.ac.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
| 2025 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
34258
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
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
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2040 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This cohort study is a case-control study from UONUMA cohort study. Using 10-year follow up data from the UONUMA Cohort Study, we will investigate the association between HTP and cancers and lifestyle-related disease. The self-administered questionnaires were delivered to residents by mail.
The research participant will be divided into four groups defined by tobacco use style: those who use conventional cigarette only, use HTP only, use both conventional cigarette and HTP, and not using any tobacco products.
The new onset diseases among the target population will be investigated using information from the electronic medical records of Uonuma Kikan Hospital, as well as information from health examinations and the Niigata Cancer Registry, while mortality events will be investigated using the Vital Statistics Death Schedule data from the MHLW.
Management information
Registered date
| 2025 | Year | 07 | Month | 20 | Day |
Last modified on
| 2025 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066928
