Clinical trial NCT03352635: Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core
Official title: Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core: Observation Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tobacco Use
Keywords: Ethnic Differences
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cigarette smokers who are Japanese American, Non-Hispanic Whites - two parents of non-Hispanic white descent or Native Hawaiians over the age of 18.

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Project 3: Analysis of 1,3-butadiene DNA adducts
timeFrame: Baseline
measure: Project 4: Correlation of DNA adducts of buccal cells and urinary markers and lung cancer risk
timeFrame: Baseline
measure: Project 2: NNK α-hydroxylation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Tobacco Research Programs University of Minnesota
state: Minnesota
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, PHD
role: PRINCIPAL_INVESTIGATOR
References: