- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02103751
Determination of Biomarkers of Exposure and Biomarkers of Potential Harm in Asian Adult Cigarette Smokers
A Multi-center Study to Determine the Levels of Biomarkers of Potential Harm and Biomarkers of Exposure to Cigarette Smoke in Asian Adult Smokers and Non-smokers
Study Overview
Detailed Description
Since Japanese mortality associated with cardiovascular disease (CVD) is lower than that in the USA although Japan is one of the top four tobacco consuming countries, this study aims to determine biomarkers of both level of exposure and CVD-related biological effects in Japanese smokers compared to non-smokers.
Biomarkers of Exposure (BoExp) include 2-naphthylamine (2-NA), 4-aminobiphenyl (4-ABP), 4-(methylnitrosaminoi)-1-(3-pyridil)-1-butanone (NNK), carbon monoxide (CO), nicotine, pyrene and 0-toluidine (o-TOL). CVD-related biomarkers include white blood cell (WBC) count, high sensitivity C-reactive protein (hs-CRP) and homocysteine in plasma; complemented with urinary 8-epi-prostaglandin F2α (8-epi-PGF2α), plasma malondialdehyde (MDA), urinary 11-DTXB2, plasma fibrinogen, high-density lipoprotein-cholesterol, triglycerides, sICAM-1, sVCAM-1 and von Willebrand Factor.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tokyo, Japan
- Bio-Iatric Centre, Research Institute for Clinical Pharmacology, Kitasato University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Smokers have smoked commercially available conventional cigarettes (CC)
- With a minimum consumption of 10 CC per day for the last 5 years
Exclusion Criteria:
- Any prior medical condition or chronic disease
- Recent infection
- History of cancer
- Use of concomitant medication
- History of alcohol abuse
- Pregnant women
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The level of biomarkers of Exposure (BoExp) to HPHCs - present in cigarette smoke - in Asian smokers compared to non smokers
Time Frame: At Visit 2 (up to14 days after Visit 1)
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To measure the level of smoking, at baseline the Fagerstrom nicotine dependence test and urinary cotinine are measured.
For measurement of biomarkers of exposure, blood and 24 hour urine sampling are performed at V2.
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At Visit 2 (up to14 days after Visit 1)
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The level of CVD-related biomarkers in Asian smokers compared to non smokers
Time Frame: At Visit 2 (up to14 days after Visit 1)
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At Visit 2 (up to14 days after Visit 1)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Prof. Tomoko Hasunuma, MD, Kitasato University, Tokyo, Japan
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CS06-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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