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Ethnic/Racial Differences in Metabolism and DNA Adduct Formation

Ethnic/Racial Differences in Metabolism and DNA Adduct Formation by 1,3-butadiene

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03421678
Enrollment
0
Registered
2018-02-05
Start date
2020-10-31
Completion date
2023-06-30
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

DIAGNOSTIC_TESTUrine Sample

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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Masonic Cancer Center, University of Minnesota
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026