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

NCT ID: NCT03352635

Last Updated: 2017-11-24

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2022-08-30

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.

Conditions

Tobacco Use

Keywords

Ethnic Differences

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Native Hawaiians

One parent of Hawaiian descent.

No interventions assigned to this group

Japanese Americans

Two parents of Japanese descent.

No interventions assigned to this group

Non-Hispanic Whites

Two parents of non-Hispanic white descent.

No interventions assigned to this group

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorothy Hatsukami, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Tobacco Research Programs University of Minnesota

Minneapolis, Minnesota, United States

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

5P01CA138388-06

Identifier Type: -

Identifier Source: org_study_id