跳至主要内容
临床试验/NCT03750825
NCT03750825进行中(未招募)不适用

Are Smokers Switching to Vaping at Lower Risk for Cancer?

University of Southern California2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
2
主要终点
Genetic changes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
22 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

Genetic changes

时间窗: 3 months

Number and location of DNA damage

Epigenetic changes

时间窗: 3 months

Number of epigenetic marks

次要结局

  • Histone modifications(Every 2 weeks for 3 months)
  • Mutation(Every 2 weeks for 3 months)
  • Gene expression(Every 2 weeks for 3 months)
  • DNA methylation(Every 2 weeks for 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmad Besaratinia

Professor

University of Southern California

研究点 (2)

Loading locations...

相似试验