Ethnic/Racial Differences in Metabolism and DNA Adduct Formation

Ethnic/Racial Differences in Metabolism and DNA Adduct Formation by 1,3-butadiene

The study will investigate the role of 1,3-butadiene metabolic activation and deactivation in lung cancer risk among various ethnic/racial groups. This project will require urine samples from smokers and nonsmokers from the three ethnic/racial groups recruited by the Clinical and Biomarker Core for the analysis of 1,3-butadiene DNA adducts. Data on nicotine intake (urinary TNE) in these subjects as well as in 400 lung cancer cases and 400 controls from Project 1 will be also required for this project.

Study Overview

• Status: Withdrawn
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: Urine Sample

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 300 smokers will be recruited from the Multiethnic Cohort (MEC) study or the general population in Hawai'i

Description

Inclusion Criteria:

• One of the three targeted ethnic groups:

  • Japanese American - two parents of Japanese descent
  • Non-Hispanic Whites - two parents of non-Hispanic white descent
  • Native Hawaiians will include individuals with at least one parent of Hawaiian descent;
• Smoke 5 cigarettes per day over the past three months;
• >21 years of age;
• Consumes 14 or fewer drinks of alcohol per week;
• Generally stable and good health (determined by review of medical history);
• Able to provide written voluntary consent before performance of any study related procedure.

Exclusion Criteria:

• Current use of other nicotine containing products for > 4 times per month (and no use of any nicotine-containing products except cigarettes for 2 weeks prior to their study visits);
• Acute or uncontrolled medical or psychiatric conditions;
• Currently taking any medications that affect relevant metabolic enzymes or anti- inflammatory medications such as ibuprofen (this will be reviewed by study investigators on a case-by-case basis);
• Active infection (e.g., influenza, cold, respiratory infection, sinus infection) at the time of the visit;
• Pregnant or nursing or planning on becoming pregnant during the study;
• Unable to read and understand English.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Japanese American; Two parents of Japanese descent	Diagnostic test: Urine Sample; One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine
Non-Hispanic Whites; Two parents of non-Hispanic white descent	Diagnostic test: Urine Sample; One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine
Native Hawaiians; At least one parent of Hawaiian descent	Diagnostic test: Urine Sample; One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Butadiene-DNA adducts in different ethnic groups	Investigate ethnic differences in butadiene-DNA adducts in smokers belonging to different ethnic groups.	Day 1 & 2
Butadiene-DNA adduct load in smokers with lung cancer	Investigate the association between butadiene-DNA adduct load and lung cancer development in smokers.	Day 1 & 2
Polymorphisms of carnicogen metabolizing genes	Examine how polymorphisms of carcinogen metabolizing genes influence metabolic inactivation, DNA adduct formation/repair, and toxicity of butadiene-derived epoxides.	Day 1 & 2

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Dorothy Hatsukami, Ph.D., University of Minnesota, Department of Psychiatry

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2017NTLS019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No