Smoking CessationESTxENDSNCT04244773
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)
A study testing ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in people with Smoking Cessation and Micronuclei, run by University of Bern at 5 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Micronuclei
- What is being tested?
- ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,246 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 18 Nov 2019to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- Persons aged 18 or older
- Currently smoking 5 or more cigarettes a day for at least 12 months
- Willing to try to quit smoking within the next 3 months,
- Persons providing a valid phone number, a valid email address and/or a valid postal address.
Who cannot join
- Known hypersensitivity or allergy to contents of the e-liquid Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study
- Persons having used ENDS regularly in the 3 months preceding the baseline visit
- Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit
- Persons who cannot attend the 6- month follow-up visit for any reason
- Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites
University Clinic for General Internal Medicine, Bern University Hospital
Bern, 3010
Département de médecine interne, Hôpitaux universitaires de Genève
Geneva, 1211
Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne
Lausanne, Canton of Vaud, 1011
Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen
Sankt Gallen
Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich
Zurich
About this study
Official title: Substudy of Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS Trial)- the Micronuclei Substudy of ESTxENDS
--> 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.
Read more
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.
- Conditions
- Smoking Cessation, Micronuclei
- Being tested
- ENDS (vaporizer/e-cig) and smoking cessation counseling, Smoking cessation counseling
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDS (vaporizer/e-cig) and smoking cessation counselingOther
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 will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
Smoking cessation counselingOther
Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: ENDS and smoking cessation | Experimental | Not described Receives: Other: ENDS (vaporizer/e-cig) and smoking cessation counseling |
| Control group: Smoking cessation counseling | Active comparator | Not described Receives: Other: Smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of buccal micronuclei_1
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
Measured: Baseline
Frequency of buccal micronuclei_2
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
Measured: 6 months post quit date
Frequency of buccal micronuclei_3
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
Measured: 12 months post quit date
Frequency of buccal micronuclei_4
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
Measured: 24 months post quit date
Secondary outcomes (1)
Change of frequency of buccal micronuclei
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
Measured: Change from baseline to 6,12, 24 months post quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start18 Nov 2019
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne, University of Geneva, Switzerland, University of Zurich, State Hospital, St. Gallen, Swiss National Science Foundation, Krebsforschung Schweiz, Bern, Switzerland, Federal Office of Public Health, Switzerland
- Responsible party
- Sponsor
- Investigators
- Reto Auer, Prof.Dr.med., Study director, Berner Institut für Hausarztmedizin; Universität BernNancy Hopf, PD Dr., Principal investigator, Centre universitaire de médecine générale et santé publique, Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244773
- Sponsor's protocol ID
- 2017-02332i
- Other IDs
- 2017
- Acronym
- ESTxENDS
- Status last verified
- Nov 2023
- First submitted
- 24 Jan 2020
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bloching M, Hofmann A, Lautenschlager C, Berghaus A, Grummt T. Exfoliative cytology of normal buccal mucosa to predict the relative risk of cancer in the upper aerodigestive tract using the MN-assay. Oral Oncol. 2000 Nov;36(6):550-5. doi: 10.1016/s1368-8375(00)00051-8.
PubMed 11036250Casartelli G, Bonatti S, De Ferrari M, Scala M, Mereu P, Margarino G, Abbondandolo A. Micronucleus frequencies in exfoliated buccal cells in normal mucosa, precancerous lesions and squamous cell carcinoma. Anal Quant Cytol Histol. 2000 Dec;22(6):486-92.
PubMed 11147304Franco T, Trapasso S, Puzzo L, Allegra E. Electronic Cigarette: Role in the Primary Prevention of Oral Cavity Cancer. Clin Med Insights Ear Nose Throat. 2016 Oct 17;9:7-12. doi: 10.4137/CMENT.S40364. eCollection 2016.
PubMed 27773997Nersesyan A, Muradyan R, Kundi M, Knasmueller S. Impact of smoking on the frequencies of micronuclei and other nuclear abnormalities in exfoliated oral cells: a comparative study with different cigarette types. Mutagenesis. 2011 Mar;26(2):295-301. doi: 10.1093/mutage/geq092. Epub 2010 Nov 2.
PubMed 21044989El-Setouhy M, Loffredo CA, Radwan G, Abdel Rahman R, Mahfouz E, Israel E, Mohamed MK, Ayyad SB. Genotoxic effects of waterpipe smoking on the buccal mucosa cells. Mutat Res. 2008 Aug-Sep;655(1-2):36-40. doi: 10.1016/j.mrgentox.2008.06.014.
PubMed 18662802Tolbert PE, Shy CM, Allen JW. Micronuclei and other nuclear anomalies in buccal smears: a field test in snuff users. Am J Epidemiol. 1991 Oct 15;134(8):840-50. doi: 10.1093/oxfordjournals.aje.a116159.
PubMed 1951279
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substudy of Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS Trial)- the Micronuclei Substudy of ESTxENDS
- ClinicalTrials.gov ID
- NCT04244773
- Acronym / sponsor ID
- ESTxENDS / 2017-02332i
- Conditions
- Smoking Cessation, Micronuclei
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,246 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- University of Lausanne, University of Geneva, Switzerland, University of Zurich, State Hospital, St. Gallen, Swiss National Science Foundation, Krebsforschung Schweiz, Bern, Switzerland, Federal Office of Public Health, Switzerland
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
--> 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: ENDS and smoking cessation | Experimental | Other: ENDS (vaporizer/e-cig) and smoking cessation counseling |
| Control group: Smoking cessation counseling | Active comparator | Other: Smoking cessation counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent as documented by signature
- Persons aged 18 or older
- Currently smoking 5 or more cigarettes a day for at least 12 months
- Willing to try to quit smoking within the next 3 months,
- Persons providing a valid phone number, a valid email address and/or a valid postal address.
Key exclusion criteria (7 listed)
- Known hypersensitivity or allergy to contents of the e-liquid Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study
- Persons having used ENDS regularly in the 3 months preceding the baseline visit
- Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDS (vaporizer/e-cig) and smoking cessation counselingParticipants 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 will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit. | Other | Intervention group: ENDS and smoking cessation |
| Smoking cessation counselingParticipants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit. | Other | Control group: Smoking cessation counseling |
Primary outcome
Frequency of buccal micronuclei_1
Time frame: Baseline
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
Frequency of buccal micronuclei_2
Time frame: 6 months post quit date
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
Frequency of buccal micronuclei_3
Time frame: 12 months post quit date
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
Frequency of buccal micronuclei_4
Time frame: 24 months post quit date
MN frequency will be calculated as number of cells that contain MNs divided by the total number counted. A minimum of 1000 cells will be counted per participant.
1 secondary outcome
Change of frequency of buccal micronuclei
Time frame: Change from baseline to 6,12, 24 months post quit date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Background: PubMed 11036250Bloching M, Hofmann A, Lautenschlager C, Berghaus A, Grummt T. Exfoliative cytology of normal buccal mucosa to predict the relative risk of cancer in the upper aerodigestive tract using the MN-assay. Oral Oncol. 2000 Nov;36(6):550-5. doi: 10.1016/s1368-8375(00)00051-8.
- Background: PubMed 11147304Casartelli G, Bonatti S, De Ferrari M, Scala M, Mereu P, Margarino G, Abbondandolo A. Micronucleus frequencies in exfoliated buccal cells in normal mucosa, precancerous lesions and squamous cell carcinoma. Anal Quant Cytol Histol. 2000 Dec;22(6):486-92.
- Background: PubMed 27773997Franco T, Trapasso S, Puzzo L, Allegra E. Electronic Cigarette: Role in the Primary Prevention of Oral Cavity Cancer. Clin Med Insights Ear Nose Throat. 2016 Oct 17;9:7-12. doi: 10.4137/CMENT.S40364. eCollection 2016.
- Background: PubMed 21044989Nersesyan A, Muradyan R, Kundi M, Knasmueller S. Impact of smoking on the frequencies of micronuclei and other nuclear abnormalities in exfoliated oral cells: a comparative study with different cigarette types. Mutagenesis. 2011 Mar;26(2):295-301. doi: 10.1093/mutage/geq092. Epub 2010 Nov 2.
- Background: PubMed 18662802El-Setouhy M, Loffredo CA, Radwan G, Abdel Rahman R, Mahfouz E, Israel E, Mohamed MK, Ayyad SB. Genotoxic effects of waterpipe smoking on the buccal mucosa cells. Mutat Res. 2008 Aug-Sep;655(1-2):36-40. doi: 10.1016/j.mrgentox.2008.06.014.
- Background: PubMed 1951279Tolbert PE, Shy CM, Allen JW. Micronuclei and other nuclear anomalies in buccal smears: a field test in snuff users. Am J Epidemiol. 1991 Oct 15;134(8):840-50. doi: 10.1093/oxfordjournals.aje.a116159.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reto Auer, Prof.Dr.med. study director
Berner Institut für Hausarztmedizin; Universität Bern
Nancy Hopf, PD Dr. principal investigator
Centre universitaire de médecine générale et santé publique, Lausanne
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in people with Smoking Cessation and Micronuclei, run by University of Bern at 5 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of buccal micronuclei_1 (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04244773, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.