Are Smokers Switching to Vaping at Lower Risk for Cancer? (Electronic Cigarettes and Cancer Risk)
Running, not enrolling · Not applicable
Conditions studied: Cigarette Smoking
In brief
This project will address a growing public health concern, namely, the health risks or benefits of e-cig use relative to cigarette smoking. The investigators will use biomarkers of early effects of relevance to cancer to determine the carcinogenic potential of e-cig use relative to cigarette smoking in oral epithelium, which is a target tissue for smoking-associated cancer. The study population will consist of one group of smokers who are interested in switching to e-cig use (Grp 1), one group of smokers who do not intend to change their smoking habits (Grp 2), and one group of non-users who would like to maintain their nonsmoking non-vaping status (Grp 3); The total number of participants in this project is 150 (n = 50, each group). The investigators will use an integrative 'multi-omics' approach complemented with single-locus/gene validation analyses to detect temporal changes in the genome, epigenome, and transcriptome relevant to cancer in the oral cells of the participants as the intervention progresses.
Key facts
- Study ID
- NCT03750825
- Run by
- University of Southern California
- People needed
- 150
- Starts
- 2021-12-01
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2025-08-06
Who can join
Age: 22 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Being male or female between the ages of 22-55;
- Being able to read and write in English and understand and give informed consent;
- Giving consent to strictly follow the study protocol throughout the study;
- Not planning to move, take an extended vacation, or undergo surgery during the study;
- Reporting smoking of > 5 manufactured cigarettes per day for at least 1 year (applicable to participants who will undergo intervention with e-cig (Grp 1) or continue to smoke (Grp 2) only); and
- Presenting with an expired air CO measurement of > 7 parts per million (ppm) at baseline (applicable to participants who will undergo intervention with e-cig (Grp 1) or continue to smoke (Grp 2) only).
You may not qualify if…
- Having oral infection/inflammation, gum disease, dental decay, immune system disorders, diabetes, respiratory diseases (e.g., asthma), or kidney diseases;
- Having any unstable or significant medical condition (e.g., symptomatic heart conditions) in the past 12 months ;
- Having body mass index < 18 kg/m2 or > 40 kg/m2
- Being pregnant or having a baby in the past 12 months;
- Having uncontrolled mental illness or substance abuse (e.g., alcoholism) or inpatient treatment for those conditions in the past 12 months;
- Having used recreational or illicit drugs in the past 3 months;
- Having used any medication known to induce/inhibit CYP450 2A6 enzyme;
- Having any known allergy to propylene glycol/vegetable glycerin (applicable participants who will undergo intervention with e-cig (Grp 1) only); and
- Having another member of household participating in the study.
Where it is running
- University of Southern California, Health Sciences Campus — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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