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Ethnic/Racial Differences in Metabolism and DNA Adduct Formation

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Withdrawn

Conditions

Lung Cancer

Treatments

Diagnostic Test: Urine Sample

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT03421678
2017NTLS019

Details and patient eligibility

About

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.

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

0 participants in 3 patient groups

Japanese American
Description:
Two parents of Japanese descent
Treatment:
Diagnostic Test: Urine Sample
Non-Hispanic Whites
Description:
Two parents of non-Hispanic white descent
Treatment:
Diagnostic Test: Urine Sample
Native Hawaiians
Description:
At least one parent of Hawaiian descent
Treatment:
Diagnostic Test: Urine Sample

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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