Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ethnic/Racial Differences in Metabolism and DNA Adduct Formation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03421678
Recruitment Status : Withdrawn (Study was completed at other sites)
First Posted : February 5, 2018
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief Summary:
The study will investigate the role of 1,3-butadiene metabolic activation and deactivation in lung cancer risk among various ethnic/racial groups. This project will require urine samples from smokers and nonsmokers from the three ethnic/racial groups recruited by the Clinical and Biomarker Core for the analysis of 1,3-butadiene DNA adducts. Data on nicotine intake (urinary TNE) in these subjects as well as in 400 lung cancer cases and 400 controls from Project 1 will be also required for this project.

Condition or disease Intervention/treatment
Lung Cancer Diagnostic Test: Urine Sample

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Ethnic/Racial Differences in Metabolism and DNA Adduct Formation by 1,3-butadiene
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Japanese American
Two parents of Japanese descent
Diagnostic Test: Urine Sample
One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine

Non-Hispanic Whites
Two parents of non-Hispanic white descent
Diagnostic Test: Urine Sample
One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine

Native Hawaiians
At least one parent of Hawaiian descent
Diagnostic Test: Urine Sample
One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine




Primary Outcome Measures :
  1. Butadiene-DNA adducts in different ethnic groups [ Time Frame: Day 1 & 2 ]
    Investigate ethnic differences in butadiene-DNA adducts in smokers belonging to different ethnic groups.

  2. Butadiene-DNA adduct load in smokers with lung cancer [ Time Frame: Day 1 & 2 ]
    Investigate the association between butadiene-DNA adduct load and lung cancer development in smokers.

  3. Polymorphisms of carnicogen metabolizing genes [ Time Frame: Day 1 & 2 ]
    Examine how polymorphisms of carcinogen metabolizing genes influence metabolic inactivation, DNA adduct formation/repair, and toxicity of butadiene-derived epoxides.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Approximately 300 smokers will be recruited from the Multiethnic Cohort (MEC) study or the general population in Hawai'i
Criteria

Inclusion Criteria:

  • One of the three targeted ethnic groups:

    • Japanese American - two parents of Japanese descent
    • Non-Hispanic Whites - two parents of non-Hispanic white descent
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421678


Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota, Department of Psychiatry
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT03421678    
Other Study ID Numbers: 2017NTLS019
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No