UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021921 |
|---|---|
| Receipt number | R000025002 |
| Scientific Title | Exploratory study of smoking-specific biomarkers of effect in healthy adult smokers and non-smokers |
| Date of disclosure of the study information | 2016/04/15 |
| Last modified on | 2018/11/13 17:27:25 |
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Basic information
Public title
Exploratory study of smoking-specific biomarkers of effect in healthy adult smokers and non-smokers
Acronym
A study on biomarkers of effect in smokers and non-smokers
Scientific Title
Exploratory study of smoking-specific biomarkers of effect in healthy adult smokers and non-smokers
Scientific Title:Acronym
A study on biomarkers of effect in smokers and non-smokers
Region
| Japan |
Condition
Condition
Smokers, non-smokers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore smoking-specific biomarkers of effect in smokers and non-smokers.
Basic objectives2
Others
Basic objectives -Others
To explore smoking-specific biomarkers of effect in smokers and non-smokers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare biomarker of effect levels between smokers and non-smokers and investigate specificity to smoking
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
| 21 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who sign the study-specific consent form
2. Subjects who are confirmed to be in good health through the screening process
3. For smokers, subjects who had regularly smoked at least 10 commercial cigarettes containing 3 mg or more tar every day for at least one year prior to screening
4. For non-smokers, subjects who had not regularly smoked commercial cigarettes
etc.
Key exclusion criteria
1. Subjects who have regular use experience of hand-rolled cigarette, cigarillo, cigar, pipe, smokeless tobacco or chewing tobacco
2. Subjects who donate 200ml or more of blood within 4 weeks before screening, or who donate 400ml or more of blood within 12 weeks before screening (including blood donation)
etc.
Target sample size
396
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Futamura |
Organization
JAPAN TOBACCO INC.
Division name
Scientific Product Assessment Center, R&D Group, Tobacco Business Headquarters
Zip code
Address
6-2, Umegaoka, Aoba-ku, Yokohama, Kanagawa
TEL
045-973-5611
yasuyuki.futamura@jt.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aki Nonaka |
Organization
JAPAN TOBACCO INC.
Division name
Scientific Product Assessment Center, R&D Group, Tobacco Business Headquarters
Zip code
Address
6-2, Umegaoka, Aoba-ku, Yokohama, Kanagawa
TEL
045-973-5611
Homepage URL
aki.nonaka@jt.com
Sponsor or person
Institute
JAPAN TOBACCO INC.
Institute
Department
Personal name
Funding Source
Organization
JAPAN TOBACCO INC.
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
Address
Tel
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
| 2016 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This study result shows that partial biomarkers of effect were affected by factor of smoking habit.
The main result reported as a poster presentation at the 32th Annual Meeting of Japanese Society of Clinical Pharmacology and Therapeutics in 2011.
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
Completed
Date of protocol fixation
| 2007 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: cross-sectional study
Recruitment method: the Heishinkai (OPHAC Hospital) recruited healthy smokers and nonsmokers
Recruitment period: from 2007 to 2008
Measurement item: oxidative stress markers etc.
Management information
Registered date
| 2016 | Year | 04 | Month | 15 | Day |
Last modified on
| 2018 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025002
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
