Ethnic/Racial Differences in Metabolism and DNA Adduct Formation

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03421678
• Other study ID #: 2017NTLS019
• Status: Withdrawn
• Start date: October 2020
• Est. completion date: June 2023

Study information

• Verified date: September 2020
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Butadiene-DNA adducts in different ethnic groups	Investigate ethnic differences in butadiene-DNA adducts in smokers belonging to different ethnic groups.	Day 1 & 2
Primary	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
Primary	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