Ethnic/Racial Differences in Metabolism and DNA Adduct Formation

Withdrawn

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: Urine Sample

• Registration Number: NCT03421678
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Study Start: 2020-10
• Last Update Posted: 2020-10-05
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Native Hawaiians	Urine Sample	At least one parent of Hawaiian descent
Japanese American	Urine Sample	Two parents of Japanese descent
Non-Hispanic Whites	Urine Sample	Two parents of non-Hispanic white descent

Primary Outcome Measures

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