- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03352635
Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core
Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core: Observation Study
Study Overview
Status
Conditions
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 Type
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Masonic Cancer Center, University of Minnesota
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Minneapolis, Minnesota, United States, 55414
- Tobacco Research Programs University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Native Hawaiians
One parent of Hawaiian descent.
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Japanese Americans
Two parents of Japanese descent.
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Non-Hispanic Whites
Two parents of non-Hispanic white descent.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Project 3: Analysis of 1,3-butadiene DNA adducts
Time Frame: Baseline
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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.
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Baseline
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Project 4: Correlation of DNA adducts of buccal cells and urinary markers and lung cancer risk
Time Frame: Baseline
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DNA adduct levels in oral cells, themselves or together with urinary biomarker levels, correlate with lung cancer risk across various ethnic/racial groups
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Baseline
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Project 2: NNK α-hydroxylation
Time Frame: Baseline
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Analysis of biomarkers of NNK α-hydroxylation (bioactivation) pathway and the effect of P450 2A6 activity on this process.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5P01CA138388-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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