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| Name | Class |
|---|---|
| University of California | OTHER |
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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.
Electronic cigarettes (e-cig) are increasingly popular among adult smokers and adolescent never smokers. Chemical analyses of e-cig vapor and liquid have shown the presence of many of the same carcinogens as those found in cigarette smoke, albeit in generally lower concentrations. However, the carcinogenic potential of e-cig has not been investigated in e-cig users (otherwise known as 'vapers'). The investigators will investigate the cancer-causing potential of e-cig use as compared to cigarette smoking by quantifying molecular changes linked to risk of cancer in smokers who switch to e-cig use vs. those who maintain their smoking habits. Leveraging a source population for ongoing studies on e-cig, the investigators will recruit smokers who are interested in switching to e-cig use, and two control groups of non-vapers, including smokers and nonsmokers who do not intend to change their smoking and nonsmoking status, respectively (n = 50, each group). Smokers consenting to switch completely to e-cig will be assigned to a 3-month intervention with a standard e-cig with fully described product characteristics. Control groups will maintain their smoking/nonsmoking habits during the intervention. At weekly intervals, the investigators will verify participants' compliance through personal interviews, CO breath tests, cotinine quantification, and vaping/smoking topography measurements. The investigators will use a non-invasive brushing technique to collect oral cells from the inside of the cheeks of all participants at baseline and every 2 weeks, afterwards. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vapers | Experimental | Smokers will switch to NIDA Standard Research E-cigarette (SREC). |
|
| Smokers | No Intervention | Smokers will continue to smoke. | |
| Nonsmokers non-vapers | No Intervention | Control nonsmokers non-vapers will continue to refrain from smoking or vaping. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIDA Standard Research E-cigarette (SREC) | Device | Smokers will switch to NIDA Standard Research E-cigarette (SREC). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Genetic changes | Number and location of DNA damage | 3 months |
| Epigenetic changes | Number of epigenetic marks | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression | Relative gene expression | Every 2 weeks for 3 months |
| DNA methylation | Pattern and distribution of aberrant DNA methylation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad Besaratinia | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California, Health Sciences Campus | Los Angeles | California | 90033 | United States |
There is no plan to make individual participant data (IPD) available to other researchers.
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| Every 2 weeks for 3 months |
| Histone modifications | Pattern and distribution of histone marks | Every 2 weeks for 3 months |
| Mutation | Frequency and location of mutations | Every 2 weeks for 3 months |