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

• ClinicalTrials.gov Identifier: NCT03352635
• Recruitment Status: Withdrawn
• First Posted: November 24, 2017
• Last Update Posted: November 24, 2017
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease
Tobacco Use

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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core: Observation Study
• Estimated Study Start Date: September 1, 2017
• Estimated Primary Completion Date: August 30, 2021
• Estimated Study Completion Date: August 30, 2022

Groups and Cohorts

Group/Cohort
Native Hawaiians; One parent of Hawaiian descent.
Japanese Americans; Two parents of Japanese descent.
Non-Hispanic Whites; Two parents of non-Hispanic white descent.

Outcome Measures

Primary Outcome Measures :

1. Project 3: Analysis of 1,3-butadiene DNA adducts [ Time Frame: 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.
2. Project 4: Correlation of DNA adducts of buccal cells and urinary markers and lung cancer risk [ Time Frame: Baseline ]
   DNA adduct levels in oral cells, themselves or together with urinary biomarker levels, correlate with lung cancer risk across various ethnic/racial groups
3. Project 2: NNK α-hydroxylation [ Time Frame: Baseline ]
   Analysis of biomarkers of NNK α-hydroxylation (bioactivation) pathway and the effect of P450 2A6 activity on this process.

Biospecimen Retention:   Samples With DNA

Plasma, buffy coat, and red cells; mouthwash and buccal cells samples; urine.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

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.

Contacts and Locations

Locations

United States, Minnesota

Tobacco Research Programs University of Minnesota

Minneapolis, Minnesota, United States, 55414

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Dorothy Hatsukami, PHD; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03352635
• Other Study ID Numbers: 5P01CA138388-06
• First Posted: November 24, 2017
• Last Update Posted: November 24, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Hatsukami). Data will be available in two formats. One will be a summary of the data, with graphs and tables, posted as pdf files and as raw individual-level data for analysis. Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used, and co-authorship is not required as a condition for receiving data. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota.
• Supporting Materials: Study Protocol
• Time Frame: Data will not be available until primary papers are accepted for publication.
• Access Criteria: Persons requesting data must do so in writing, identifying the affiliation and how the data will be used.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota:

Ethnic Differences