Status:
WITHDRAWN
Ethnic/Racial Differences in Metabolism and DNA Adduct Formation
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Lung Cancer
Eligibility:
All Genders
21+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03421678
Start Date
October 1 2020
End Date
June 1 2023
Last Update
October 5 2020
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