Ethnic/Racial Differences in Metabolism and DNA Adduct Formation

NCT03421678 | Withdrawn

• 1 other identifier: 2017NTLS019
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Japanese American

Two parents of Japanese descent

Diagnostic Test: Urine Sample

Non-Hispanic Whites

Two parents of non-Hispanic white descent

Diagnostic Test: Urine Sample

Native Hawaiians

At least one parent of Hawaiian descent

Diagnostic Test: Urine Sample

Interventions

Urine Sample DIAGNOSTIC_TEST

One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine

Japanese American; Native Hawaiians; Non-Hispanic Whites

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dorothy Hatsukami, Ph.D.

  University of Minnesota, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 5, 2018
• Study Start: October 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 5, 2020

Record last verified: 2020-09