UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049494 |
|---|---|
| Receipt number | R000056363 |
| Scientific Title | An Observational Survey in Japan to Explore Health Outcomes Associated with the Use of Heated Tobacco Products |
| Date of disclosure of the study information | 2022/11/14 |
| Last modified on | 2024/10/16 13:22:02 |
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Basic information
Public title
An Observational Survey in Japan to Explore Health Outcomes Associated with the Use of Heated Tobacco Products
Acronym
An Observational Cross-Sectional Survey in Japan
Scientific Title
An Observational Survey in Japan to Explore Health Outcomes Associated with the Use of Heated Tobacco Products
Scientific Title:Acronym
An Observational Cross-Sectional Survey in Japan
Region
| Japan |
Condition
Condition
Cancer, Cardiovascular disease, Respiratory disease, Dental disease
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the development of smoking-related diseases* or symptoms in heated tobacco product users, and the incidence rates in contrast with non-smokers and cigarette smokers.
*Shown or suggested to be associated with smoking in "The report of the study group on the health effects of smoking" [ Translated from Japanese. ] by Ministry of Health, Labour and Welfare.
Basic objectives2
Others
Basic objectives -Others
To explore the smoking status of heated tobacco products users prior to initiation of heated tobacco products use and the impact of that smoking status on the primary endpoints.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of smoking-related diseases and symptoms associated with smoking-related diseases in each group and their ratios between groups.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Subjects who sign the study-specific consent form
-Heated Tobacco Product Users:
Subjects who use Heated Tobacco exclusively more than six months
-Cigarette Smokers:
Subjects who smoke cigarettes exclusively more than six months
-Non-smokers:
Subjects who have never used tobacco products
Key exclusion criteria
-Subjects who are employed in the tobacco industries, CRO or clinical facility.
Target sample size
40000
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
JAPAN TOBACCO INC.
Division name
Scientific and Regulatory Affairs, Tobacco Business
Zip code
105-6927
Address
Kamiyacho Trust tower, 4-4-1, Toranomon, Minato-Ku, Tokyo
TEL
080-8131-5689
naoki.miura@jt.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kimura |
Organization
JAPAN TOBACCO INC.
Division name
Scientific and Regulatory Affairs, Tobacco Business
Zip code
105-6927
Address
Kamiyacho Trust tower, 4-4-1, Toranomon, Minato-Ku, Tokyo
TEL
070-4179-6591
Homepage URL
yuki.kimura@jt.com
Sponsor or person
Institute
JAPAN TOBACCO INC.
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health Outcome Research Institute
Address
1-23-26-400, Ichikawa, Ichikawa-Shi, Chiba
Tel
N/A
info@hor-i.org
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
| 2022 | Year | 11 | Month | 14 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1186/s12889-024-20257-7
Number of participants that the trial has enrolled
17406
Results
Almost all participating current exclusive HTP users had a history of long-term smoking (mean: 30.8 years), and the occurrence of outcomes both before and after the start using HTP was reported. The ORs, without adjustment and with adjustment for smoking history before HTP use were, 3.23 (95% CI: 1.37-7.61) and 1.85 (95% CI: 0.70-4.89) respectively in COPD, same as other outcomes.
Results date posted
| 2024 | Year | 10 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants in each group from whom responses to the questionnaires in this survey were obtained were matched by sex and age (5-year age groups) based on the HTP group.
Participant flow
The screening survey questionnaire was sent to 1,400,735 people in the registration panel of the survey company and participants who met the inclusion criteria for each group were selected. The selected participants were sent the questionnaire for this study, and of the participants in each group from whom responses were obtained, participants in the CC group and never-user group were selected to match the sex and age (5-year age groups) in the HTP group. As a result, the incidence rates of outcomes were compared between the groups using the responses of 5,802 participants in each group.
Adverse events
N/A
Outcome measures
Incidence of smoking-related diseases and symptoms associated with smoking-related diseases in each group and their ratios between groups.
Plan to share IPD
No plans to share
IPD sharing Plan description
No plans to share
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational cross-sectional survey using a Web-based questionnaire with the heated tobacco product group as the target group and the cigarette smokers and non-smokers group as the comparison and control group. The survey period will be 1.5 weeks. Eligible participants of the heated tobacco product group and the cigarette smokers' group are those who have been using continuously heated tobacco products or cigarettes for at least 6 months backward from the study date.
In each group, the development of cardiovascular, respiratory, other diseases and symptoms related to these diseases will be explored.
Management information
Registered date
| 2022 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056363
