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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021921
Receipt No. 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

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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
Email 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
Email aki.nonaka@jt.com

Sponsor
Institute JAPAN TOBACCO INC.
Institute
Department

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
Email

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
URL(English) https://upload.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


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