Ethnic/Racial Differences in Metabolism and DNA Adduct Formation

NCT ID: NCT03421678

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2023-06-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Japanese American

Two parents of Japanese descent

Urine Sample

Intervention Type: 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

Non-Hispanic Whites

Two parents of non-Hispanic white descent

Urine Sample

Intervention Type: 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

Native Hawaiians

At least one parent of Hawaiian descent

Urine Sample

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorothy Hatsukami, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota, Department of Psychiatry

Other Identifiers

2017NTLS019

Identifier Type: -

Identifier Source: org_study_id