Oral Cell DNA Adducts in Smokers

NCT03285893 | Completed Results

• 1 other identifier: 2017NTLS019
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

Brief Summary

DNA adducts in the oral mucosa cells of 100 smokers from 3 ethnic groups - Native Hawaiians, Whites, and Japanese Americans with differing risks for lung cancer upon cigarette smoking will be quantified. DNA adducts of tobacco smoke carcinogens will be quantified using both targeted and untargeted approaches.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Concentration of γ-OH-Acr-dGuo, a Major Acrolein-DNA Adduct

  Acrolein-DNA adduct (8R/S)-3-(2'-deoxyribos-1'-yl)-5,6,7,8-tetrahy- dro-8-hydroxypyrimido\[1,2-a\]purine-10(3H)-one. Model adjusted for age, sex and race/ethnicity

  Baseline

Secondary Outcomes (1)

• εdAdo, Per 10^9 Nucleotides

  Baseline

Study Arms (3)

Native Hawaiian cigarette smokers

oral cell DNA adducts

Other: oral cell DNA adducts

White (European Americans) cigarette smokers

oral cell DNA adducts

Other: oral cell DNA adducts

Japanese American cigarette smokers

oral cell DNA adducts

Other: oral cell DNA adducts

Interventions

oral cell DNA adducts OTHER

oral cells will be collected, DNA isolated, and analyzed for adducts

Japanese American cigarette smokers; Native Hawaiian cigarette smokers; White (European Americans) cigarette smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 each of three ethnic groups: Native Hawaiians, Japanese Americans, whites

You may qualify if:

• currently smoke at least 5 cigarettes per day, self-identified Japanese Americans, European Americans, or Native Hawaiians.

You may not qualify if:

• no current use of other nicotine containing products, no acute or uncontrolled medical or psychiatric conditions, no greater than 14 alcoholic drinks per week, not pregnant, not breastfeeding, not currently taking any medications that affect relevant metabolic enzymes, no active infection.

Sponsors & Collaborators

• University of Minnesota: lead
• University of Hawaii: collaborator

Study Sites (1)

Tobacco Use Research Center

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

oral cell DNA and urine

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Joni Jensen
• Organization: University of Minnesota

jense010@umn.edu

612-624-5178

Study Officials

• Stepehn Hecht, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 18, 2017
• Study Start: February 1, 2018
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 12, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-09

Locations

US (1)