Determination of Biomarkers of Exposure and Biomarkers of Potential Harm in Asian Adult Cigarette Smokers
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|ClinicalTrials.gov Identifier: NCT02103751|
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : June 19, 2014
|Condition or disease|
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 :||Observational|
|Actual Enrollment :||1069 participants|
|Observational Model:||Case Control|
|Official Title:||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 Start Date :||July 2007|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||February 2008|
- 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) ]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.
- The level of CVD-related biomarkers in Asian smokers compared to non smokers [ Time Frame: At Visit 2 (up to14 days after Visit 1) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103751
|Bio-Iatric Centre, Research Institute for Clinical Pharmacology, Kitasato University|
|Principal Investigator:||Prof. Tomoko Hasunuma, MD||Kitasato University, Tokyo, Japan|