ESTxENDS Trial: MN Substudy - Micronuclei in Buccal Epithelium, a

Status Completed

Clinical Trial Summary

--> This is a substudy of the main ESTxENDS trial (NCT03589989). Micronuclei in buccal epithelial outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989. Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer, e-cigarette or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. The micronucleus cytologic assay test was originally developed to screen for drug toxicity in bone marrow samples from mammals. The technique identifies micronuclei on smears obtained by oral cavity exfoliation and indicate genomic instability. Buccal MNs may predict cancer risk for the upper aerodigestive tract. The HUman MicroNucleus project on eXfoLiated buccal cells (HUMNXL) found MN counts gradually increased during the progression from normal mucosal to precancerous lesions to carcinoma. MN assessment discriminates between exposure to tobacco smoke in smokers and in non-smokers, and has been tested on a small number of ENDS users. For the main ESTxENDS trial (NCT03589989), cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-month period. Measures of MN frequency will test the potential effect of ENDS use on cancer-related outcomes, in particular incident of mouth-, lung- and kidney- cancers.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04244773
Study type	Interventional
Source	University of Bern
Contact
Status	Completed
Phase	N/A
Start date	November 18, 2019
Completion date	August 31, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

ESTxENDS Trial: MN Substudy - Micronuclei in Buccal Epithelium, a Surrogate Measure of Future Cancer Risk, Induced by Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig) — ESTxENDS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms