COMPLETED

Metabolism of NNK in Japanese Americans

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

STUDY 2: CLINICAL PROTOCOL Metabolism of NNK Among Japanese Americans

Quick Facts

Study Start:2020-09-01
Study Completion:2025-04-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04228952

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Japanese American - one, but preferably 2 biological parents of Japanese descent
  2. 2. 21 years or older
  3. 3. Daily smoker
  4. 4. Eligible urinary ratios of total 3-hydroxycotinine to cotinine (3HC/COT):
  5. * "Little or no-CYP2A6 activity" defined as a 3-hydroxycotinine:cotinine ratio of \<0.6 or
  6. * "Relatively high" CYP2A6 activity defined as a 3-hydroxycotinine:cotinine ratio of \>3.0.
  7. 5. Stable and good physical and mental health
  8. 6. Provided written informed consent to participate in the study
  1. 1. 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
  2. 2. Currently taking any medications that affect relevant metabolic enzymes
  3. 3. Experiencing medical conditions that might affect biomarkers of exposure and effect
  4. 4. Pregnant or nursing or planning on becoming pregnant during the study
  5. 5. Unable to read and understand English

Contacts and Locations

Principal Investigator

Dorothy K Hatsukami, Ph.D
PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota

Study Locations (Sites)

University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

  • Dorothy K Hatsukami, Ph.D, PRINCIPAL_INVESTIGATOR, Masonic Cancer Center, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-01
Study Completion Date2025-04-14

Study Record Updates

Study Start Date2020-09-01
Study Completion Date2025-04-14

Terms related to this study

Keywords Provided by Researchers

  • CYP2A6, Nicotine Metabolite Ratio, NNAL, NNK α-hydroxylation

Additional Relevant MeSH Terms

  • Smoking