Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core

Withdrawn

• Conditions: Tobacco Use

• Registration Number: NCT03352635
• Lead Sponsor: University of Minnesota

Brief Summary

The purpose of the study is to collect human biological samples and measurements from people of various ethnic and racial backgrounds for projects related to the "Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking" Program Project Grant. These samples will be used to evaluate and compare biomarkers of tobacco exposure across Japanese Americans, Whites, and Native Hawaiians and to add to the Multiethnic Cohort (MEC) biorepository to develop or assess future biomarkers.

Detailed Description

This cross-sectional, observational study will primarily recruit smokers from the MEC study. The biological samples from these smokers are being collected since they do not currently exist in the biorepository (e.g. buccal cells). Potential smokers from the three racial groups who meet specific inclusion criteria will be invited to participate in the study. Should recruitment from the MEC sample be insufficient, smokers who meet the criteria will be recruited from the general population. This study will involve one to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine.

Approximately 300 smokers will be recruited from the Multiethnic Cohort (MEC) study or the general population in Hawai'i. 100 participants from each of the three designated ethnic/racial groups: Native Hawaiians, Japanese Americans and Non-Hispanic Whites. All participants will be recruited from Hawai'i to reduce variation due to geographical location and maximize ability to recruit the targeted ethnic/racial groups.

This study will involve one to two home visits where demographics, tobacco use and exposure history, medical history and medication use, questionnaires assessing tobacco dependence, alcohol use, and environmental exposures will be administered. and biological samples will be collected including blood, buccal cells and urine.

Study Timeline

• Study First Submitted: 2017-07-25
• Study Start: 2017-09-01
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-17
• Last Update Submitted: 2017-11-17
• Study First Posted: 2017-11-24
• Last Update Posted: 2017-11-24
• Primary Completion: 2021-08-30
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. One of the three targeted ethnic groups: 1)Japanese American - two parents of Japanese descent; 2) Non-Hispanic Whites - two parents of non-Hispanic white descent; 3) Native Hawaiians will include individuals with at least one parent of Hawaiian descent;
2. Smoke 5 cigarettes per day over the past three months;
3. >21 years of age;
4. Consumes 14 or fewer drinks of alcohol per week;
5. Generally stable and good health (determined by review of medical history);
6. Able to provide written voluntary consent before performance of any study related procedure.

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Exclusion Criteria

1. 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);
2. Acute or uncontrolled medical or psychiatric conditions;
3. 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);
4. Active infection (e.g., influenza, cold, respiratory infection, sinus infection) at the time of the visit;
5. Pregnant or nursing or planning on becoming pregnant during the study;
6. Unable to read and understand English.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Project 3: Analysis of 1,3-butadiene DNA adducts	Baseline	Ethnic differences in butadiene-DNA adducts across racial groups to determine the relationship of DNA adducts to lung cancer and the influence of carcinogen metabolizing genes on DNA adduct formation, repair, and toxicity/mutagenicity.
Project 4: Correlation of DNA adducts of buccal cells and urinary markers and lung cancer risk	Baseline	DNA adduct levels in oral cells, themselves or together with urinary biomarker levels, correlate with lung cancer risk across various ethnic/racial groups
Project 2: NNK α-hydroxylation	Baseline	Analysis of biomarkers of NNK α-hydroxylation (bioactivation) pathway and the effect of P450 2A6 activity on this process.

Trial Locations

Locations (2)

Tobacco Research Programs University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States