UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study of smoking-specific biomarkers of effect in healthy adult smokers and non-smokers
Title of the study (Brief title)	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	Yasuyuki Futamura
Organization	JAPAN TOBACCO INC.
Division name	Scientific Product Assessment Center, R&D Group, Tobacco Business Headquarters
Address	6-2, Umegaoka, Aoba-ku, Yokohama, Kanagawa
TEL	045-973-5611
Email	yasuyuki.futamura@jt.com

Public contact
Name of contact person	Aki Nonaka
Organization	JAPAN TOBACCO INC.
Division name	Scientific Product Assessment Center, R&D Group, Tobacco Business Headquarters
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 09 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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