Lung Cancer Clinical Trial

Metabolism of NNK in Japanese Americans

Summary

The risk of lung cancer varies by individual and by ethnic/racial group. In this study the investigators will explore how individual differences in the metabolism of a tobacco-specific lung carcinogen may contribute to the variable risk of lung cancer between ethnic/racial groups.

In this 10 day clinical trial, Japanese Americans will smoke a cigarette containing deuterium-labeled 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), a tobacco-specific lung carcinogen. The study cigarette will be smoked for 7 days.

This will allow for NNK metabolic profiling and determining the effect of CYP2A6 genotype on the level of NNK α-hydroxylation in Japanese Americans smokers using [pyridine- D4]-NNK containing cigarettes.

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Full Description

Eligible subjects will provide a baseline 24 hour urine sample. Study cigarettes spiked with labeled NNK will be provided to the subjects to smoke over a 7 day period. During this time, 24 hour urine samples will be collected over days 5, 6 and 7 on study cigarettes. Blood will be drawn on days 6 and 7 on study cigarettes. Samples will be analyzed for NNK metabolism.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Japanese American - one, but preferably 2 biological parents of Japanese descent
21 years or older
Daily smoker

Eligible urinary ratios of total 3-hydroxycotinine to cotinine (3HC/COT):

"Little or no-CYP2A6 activity" defined as a 3-hydroxycotinine:cotinine ratio of <0.6 or
"Relatively high" CYP2A6 activity defined as a 3-hydroxycotinine:cotinine ratio of >3.0.
Stable and good physical and mental health
Provided written informed consent to participate in the study

Exclusion Criteria:

Unwilling to avoid other nicotine containing products during the study and no use of any nicotine-containing products except cigarettes for 1 week prior to their study visits
Currently taking any medications that affect relevant metabolic enzymes
Experiencing medical conditions that might affect biomarkers of exposure and effect
Pregnant or nursing or planning on becoming pregnant during the study
Unable to read and understand English

Study is for people with:

Lung Cancer

Estimated Enrollment:

50

Study ID:

NCT04228952

Recruitment Status:

Recruiting

Sponsor:

Masonic Cancer Center, University of Minnesota

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There is 1 Location for this study

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University of Hawaii Cancer Center
Honolulu Hawaii, 96813, United States More Info
Loic Le Marchand, MD, PhD.
Contact
808-564-5899
[email protected]
Loic Le Marchand, MD, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

50

Study ID:

NCT04228952

Recruitment Status:

Recruiting

Sponsor:


Masonic Cancer Center, University of Minnesota

How clear is this clinincal trial information?

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