Smoking CessationNCT01176383
Impact of a Gene Test for Susceptibility to Lung Cancer in Smokers
A study testing Respiragene test and risk score in people with Smoking Cessation, run by Sussex NHS Research Consortium at 1 site in United Kingdom.
Trial summary
Professor RP Young (Associate Professor of Medicine and Molecular Medicine, School of Biological Sciences, University of Auckland) and his team have developed a reliable genetic test "Respiragene" based on 20 single nucleotide polymorphisms that can be used (together with details of personal and family history) to… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Respiragene test and risk score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Mar 2013
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 20-70 years
- Smoking more than 10 cigarettes daily
Who cannot join
- Aged under 20 years or over 70 years
- Smoking less than 10 cigarettes daily
- History of major depression and other psychiatric conditions, dementias and serious or terminal illness (cancers etc.).
- Patients on warfarin would be excluded due to interactions between warfarin and varenicline as varenicline will be used as the modern treatment of choice for smoking cessation.
- Patients who did not wish to have a genetic test would be referred to the practice nurse for smoking cessation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Integrated Care Partnership The Old Cottage Hospital Alexandra Road,
Epsom, Surrey, KT17 4BL
About this study
Official title: A Protocol for an Randomised Controlled Trial of Smoking Cessation Success Rate With or Without a Genetic Test, "Respiragene", to Assess Lung Cancer Risk - an Exploratory Study
Professor RP Young (Associate Professor of Medicine and Molecular Medicine, School of Biological Sciences, University of Auckland) and his team have developed a reliable genetic test "Respiragene" based on 20 single nucleotide polymorphisms that can be used (together with details of personal and family history) to calculate a smoker's lifetime risk of developing lung cancer. The expectation is that whatever the score (estimated lifetime risk will vary from 5% to 50%) the result will counter "optimism bias" of the smoker and encourage smoking cessation and this assumption is supported by previous research on similar tests and smoking cessation. The investigators plan to recruit two groups of subjects for smoking cessation but only one group will have the Respiragene test. Eight weekly smoking cessation sessions will be carried out at a Surrey primary care medical centre and will follow the usual format for National Health Service smoking cessation clinics using Champix (varenicline), counselling and the carbon monoxide breath meter but with added: evaluation questionnaires, fagerstrom nicotine addiction score, salivary cotinine (metabolite of nicotine) test. The main outcome measures will be estimation of smoking cessation at 4 weeks and six months after the completion of the seven smoking cessation sessions. Successful smoking cessation has to be confirmed by negative salivary cotinine at 4 weeks and six months and questionnaires will be used to estimate the influence of the Respiragene test compared with standard procedures such as counselling and the carbon monoxide breath readings.
Read the detailed description
Despite the 5-10% probability of lung cancer in smokers, 50% do not believe they are at significantly increased risk Despite this, over 80% of smokers would like to know their personal risk of lung cancer. RP Young, a clinician at University of Auckland, has show a three way link between biomarkers for COPD, a set of 20 single nucleotide polymorphisms (SNPs) and lung cancer. He has demonstrated a strong correlation between a risk score (derived from family history of cancer, the 20 SNPs \& clinical COPD) and the development of lung cancers whereas healthy smokers (who had not developed lung cancer) matched for age, gender and lifetime smoking habits had a relatively low risk score (n=446 lung cancer subjects, 484 healthy current smokers. The odds ratio for lung cancer risk varied from 0.2-3.2 depending on the genetic risk (p<0.001). The Auckland lung cancer risk score has a 90% sensitivity for a score of >4. The validity of 20 SNP gene test has also been confirmed in populations in Barcelona, Spain and Liverpool, United Kingdom. The test has been given the trade name "Respiragene".
Small uncontrolled trials of use of Respiragene in smoking cessation clinics in New Zealand and USA show an improvement in smoking cessation at six months after a Respiragene intervention with quit rates of 30-35%. The trial hypothesis is that smokers who have the Respiragene test and a full explanation of their risk score will have a better quit rate at 4 weeks and at six months (after completion of their eight weekly smoking cessation clinic sessions) than controls. Smoking cessation at the six month follow up will bw confirmed by testing for salivary cotinine. Based on data from Young's small trial, we also hypothesise that this uplift of quit rate will be seen for subjects with both high risk scores and average risk scores (there is no low risk category for smokers). These hypotheses are the basis of the primary end points.
The investigators will also be administering the same questionnaire to each subject and control twice, at 4 weeks and six months (after the smoking cessation course) that is primarily designed to evaluate the impact of the Respiragene test in relation to other influences:
- other components of the smoking cessation clinic sessions (salivary cotinine testing, carbon monoxide breath analyser, general clinic help and advice, clinic fact sheets)
- general environmental factors (cost of cigarettes, family pressure, work regulations, doctor's advice)
The results will be analysed using Statistical Package for the Social Sciences (SPSS) Statistics 17.0 computer programme.
- Conditions
- Smoking Cessation
- Being tested
- Respiragene test and risk score
- Keywords
- Nicotine addiction, Behaviour, Gene test, Lung cancer, Lifetime risk of lung cancer in smokers
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder, Behavior, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiragene test and risk scoreGenetic
Also called Respiragene test, Lab 21, Cambridge
This 12 gene test used with other data (family history, age and spirometry result) to calculate lifetime risk of lung cancer in smokers who do not quit smoking. This intervention is expected to be a motivator to quit.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will have a standard NHS cessation clinic experience |
| Respiragene test and risk score | Experimental | Subjects will have a buccal swab taken at first attendance for a 12 gene test of SNP variants associated with risk of lung cancer. From the genetic data and clinical data (any history of COPD, family history of lung cancer in a first degree relative and age) a risk score is calculated from which a lifetime risk of lung cancer if the subject continues to smoke can be calculated. This is expected to be a powerful motivator to encourage smoking cessation. Receives: Genetic: Respiragene test and risk score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects versus controls who are non-smokers at 4 weeks and six months after completion of smoking cessation clinic
Subjects and controls will be reassessed at 4 weeks and six months after the last smoking cessation session to determine how many have genuinely stopped smoking. This will be confirmed at the six month follow up by measuring salivary cotinine to reveal any subjects who are being untruthful. The difference between quit rates in subjects and controls can then be calculated.
Measured: Nine months (from recruitment to completion)
Secondary outcomes (1)
Questionnaires to assess efficacy of Repiragene test as a motivator compared with other smoking cessation aids and motivators
All subjects will be asked to complete questionnaires (with assistance as needed) to assess the perceived value of the Respiragene test compared with other motivators (such as the price of cigarettes, family pressure etc.) and other motivational triggers used in the clinic (salivary cotinine, spirometry results etc.)
Measured: Nine months (from recruitemnt to completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startSep 2011
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sussex NHS Research Consortium
- Sponsor type
- Other government
- Collaborators
- University of Surrey, Lab 21, Cambridge, NHS Research and Development
- Responsible party
- Principal investigator, John Nichols, University of Surrey
- Investigators
- John Nichols, MB ChB, Principal investigator, Surrey Primary Care Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176383
- Sponsor's protocol ID
- SPCRU1
- Status last verified
- May 2014
- First submitted
- 3 Aug 2010
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Young RP, Hopkins RJ, Hay BA, Epton MJ, Mills GD, Black PN, Gardner HD, Sullivan R, Gamble GD. Lung cancer susceptibility model based on age, family history and genetic variants. PLoS One. 2009;4(4):e5302. doi: 10.1371/journal.pone.0005302. Epub 2009 Apr 23.
PubMed 19390575Smith SM, Campbell NC, MacLeod U, Lee AJ, Raja A, Wyke S, Ziebland SB, Duff EM, Ritchie LD, Nicolson MC. Factors contributing to the time taken to consult with symptoms of lung cancer: a cross-sectional study. Thorax. 2009 Jun;64(6):523-31. doi: 10.1136/thx.2008.096560. Epub 2008 Dec 3.
PubMed 19052045Sanderson SC, O'Neill SC, White DB, Bepler G, Bastian L, Lipkus IM, McBride CM. Responses to online GSTM1 genetic test results among smokers related to patients with lung cancer: a pilot study. Cancer Epidemiol Biomarkers Prev. 2009 Jul;18(7):1953-61. doi: 10.1158/1055-9965.EPI-08-0620. Epub 2009 Jun 30.
PubMed 19567511Young RP, Hopkins R, Black PN, Eddy C, Wu L, Gamble GD, Mills GD, Garrett JE, Eaton TE, Rees MI. Functional variants of antioxidant genes in smokers with COPD and in those with normal lung function. Thorax. 2006 May;61(5):394-9. doi: 10.1136/thx.2005.048512. Epub 2006 Feb 7.
PubMed 16467073Young RP, Hopkins RJ, Christmas T, Black PN, Metcalf P, Gamble GD. COPD prevalence is increased in lung cancer, independent of age, sex and smoking history. Eur Respir J. 2009 Aug;34(2):380-6. doi: 10.1183/09031936.00144208. Epub 2009 Feb 5.
PubMed 19196816Young RP, Hopkins RJ, Hay BA, Epton MJ, Black PN, Gamble GD. Lung cancer gene associated with COPD: triple whammy or possible confounding effect? Eur Respir J. 2008 Nov;32(5):1158-64. doi: 10.1183/09031936.00093908.
PubMed 18978134Young RP, Hopkins RJ, Hay BA, Epton MJ, Mills GD, Black PN, Gardner HD, Sullivan R, Gamble GD. A gene-based risk score for lung cancer susceptibility in smokers and ex-smokers. Postgrad Med J. 2009 Oct;85(1008):515-24. doi: 10.1136/pgmj.2008.077107.
PubMed 19789190McBride CM, Bepler G, Lipkus IM, Lyna P, Samsa G, Albright J, Datta S, Rimer BK. Incorporating genetic susceptibility feedback into a smoking cessation program for African-American smokers with low income. Cancer Epidemiol Biomarkers Prev. 2002 Jun;11(6):521-8.
PubMed 12050092Sanderson SC, Humphries SE, Hubbart C, Hughes E, Jarvis MJ, Wardle J. Psychological and behavioural impact of genetic testing smokers for lung cancer risk: a phase II exploratory trial. J Health Psychol. 2008 May;13(4):481-94. doi: 10.1177/1359105308088519.
PubMed 18420756Parkes G, Greenhalgh T, Griffin M, Dent R. Effect on smoking quit rate of telling patients their lung age: the Step2quit randomised controlled trial. BMJ. 2008 Mar 15;336(7644):598-600. doi: 10.1136/bmj.39503.582396.25. Epub 2008 Mar 6.
PubMed 18326503Young RP, Hopkins RJ, Smith M, Hogarth DK. Smoking cessation: the potential role of risk assessment tools as motivational triggers. Postgrad Med J. 2010 Jan;86(1011):26-33; quiz 31-2. doi: 10.1136/pgmj.2009.084947.
PubMed 20065338Soulier-Parmeggiani L, Griscom S, Bongard O, Avvanzino R, Bounameaux H. One-year results of a smoking-cessation programme. Schweiz Med Wochenschr. 1999 Mar 13;129(10):395-8.
PubMed 10212973Nichols JAA, Grob P, Kite W, Williams P, de Lusignan S. Using a genetic/clinical risk score to stop smoking (GeTSS): randomised controlled trial. BMC Res Notes. 2017 Oct 23;10(1):507. doi: 10.1186/s13104-017-2831-2.
PubMed 29061161Nichols JA, Grob P, de Lusignan S, Kite W, Williams P. Genetic test to stop smoking (GeTSS) trial protocol: randomised controlled trial of a genetic test (Respiragene) and Auckland formula to assess lung cancer risk. BMC Pulm Med. 2014 May 1;14:77. doi: 10.1186/1471-2466-14-77.
PubMed 24884942
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol for an Randomised Controlled Trial of Smoking Cessation Success Rate With or Without a Genetic Test, "Respiragene", to Assess Lung Cancer Risk - an Exploratory Study
- ClinicalTrials.gov ID
- NCT01176383
- Acronym / sponsor ID
- SPCRU1
- Conditions
- Smoking Cessation
- Keywords
- Nicotine addiction, Behaviour, Gene test, Lung cancer, Lifetime risk of lung cancer in smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Sussex NHS Research ConsortiumOther government
- Collaborators
- University of Surrey, Lab 21, Cambridge, NHS Research and Development
- Study start
- Sep 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 Aug 2010 (estimated)
- 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.
Professor RP Young (Associate Professor of Medicine and Molecular Medicine, School of Biological Sciences, University of Auckland) and his team have developed a reliable genetic test "Respiragene" based on 20 single nucleotide polymorphisms that can be used (together with details of personal and family history) to calculate a smoker's lifetime risk of developing lung cancer. The expectation is that whatever the score (estimated lifetime risk will vary from 5% to 50%) the result will counter "optimism bias" of the smoker and encourage smoking cessation and this assumption is supported by previous research on similar tests and smoking cessation. The investigators plan to recruit two groups of subjects for smoking cessation but only one group will have the Respiragene test. Eight weekly smoking cessation sessions will be carried out at a Surrey primary care medical centre and will follow the usual format for National Health Service smoking cessation clinics using Champix (varenicline), counselling and the carbon monoxide breath meter but with added: evaluation questionnaires, fagerstrom nicotine addiction score, salivary cotinine (metabolite of nicotine) test. The main outcome measures will be estimation of smoking cessation at 4 weeks and six months after the completion of the seven smoking cessation sessions. Successful smoking cessation has to be confirmed by negative salivary cotinine at 4 weeks and six months and questionnaires will be used to estimate the influence of the Respiragene test compared with standard procedures such as counselling and the carbon monoxide breath readings.
Detailed description
Despite the 5-10% probability of lung cancer in smokers, 50% do not believe they are at significantly increased risk Despite this, over 80% of smokers would like to know their personal risk of lung cancer. RP Young, a clinician at University of Auckland, has show a three way link between biomarkers for COPD, a set of 20 single nucleotide polymorphisms (SNPs) and lung cancer. He has demonstrated a strong correlation between a risk score (derived from family history of cancer, the 20 SNPs \& clinical COPD) and the development of lung cancers whereas healthy smokers (who had not developed lung cancer) matched for age, gender and lifetime smoking habits had a relatively low risk score (n=446 lung cancer subjects, 484 healthy current smokers. The odds ratio for lung cancer risk varied from 0.2-3.2 depending on the genetic risk (p<0.001). The Auckland lung cancer risk score has a 90% sensitivity for a score of >4. The validity of 20 SNP gene test has also been confirmed in populations in Barcelona, Spain and Liverpool, United Kingdom. The test has been given the trade name "Respiragene".
Small uncontrolled trials of use of Respiragene in smoking cessation clinics in New Zealand and USA show an improvement in smoking cessation at six months after a Respiragene intervention with quit rates of 30-35%. The trial hypothesis is that smokers who have the Respiragene test and a full explanation of their risk score will have a better quit rate at 4 weeks and at six months (after completion of their eight weekly smoking cessation clinic sessions) than controls. Smoking cessation at the six month follow up will bw confirmed by testing for salivary cotinine. Based on data from Young's small trial, we also hypothesise that this uplift of quit rate will be seen for subjects with both high risk scores and average risk scores (there is no low risk category for smokers). These hypotheses are the basis of the primary end points.
The investigators will also be administering the same questionnaire to each subject and control twice, at 4 weeks and six months (after the smoking cessation course) that is primarily designed to evaluate the impact of the Respiragene test in relation to other influences:
- other components of the smoking cessation clinic sessions (salivary cotinine testing, carbon monoxide breath analyser, general clinic help and advice, clinic fact sheets)
- general environmental factors (cost of cigarettes, family pressure, work regulations, doctor's advice)
The results will be analysed using Statistical Package for the Social Sciences (SPSS) Statistics 17.0 computer programme.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will have a standard NHS cessation clinic experience |
| Respiragene test and risk score | Experimental | Genetic: Respiragene test and risk scoreSubjects will have a buccal swab taken at first attendance for a 12 gene test of SNP variants associated with risk of lung cancer. From the genetic data and clinical data (any history of COPD, family history of lung cancer in a first degree relative and age) a risk score is calculated from which a lifetime risk of lung cancer if the subject continues to smoke can be calculated. This is expected to be a powerful motivator to encourage smoking cessation. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 20-70 years
- Smoking more than 10 cigarettes daily
Key exclusion criteria (5 listed)
- Aged under 20 years or over 70 years
- Smoking less than 10 cigarettes daily
- History of major depression and other psychiatric conditions, dementias and serious or terminal illness (cancers etc.).
- Patients on warfarin would be excluded due to interactions between warfarin and varenicline as varenicline will be used as the modern treatment of choice for smoking cessation.
- Patients who did not wish to have a genetic test would be referred to the practice nurse for smoking cessation.
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 |
|---|---|---|
| Respiragene test and risk scoreAlso: Respiragene test, Lab 21, CambridgeThis 12 gene test used with other data (family history, age and spirometry result) to calculate lifetime risk of lung cancer in smokers who do not quit smoking. This intervention is expected to be a motivator to quit. | Genetic | Respiragene test and risk score |
Primary outcome
Number of subjects versus controls who are non-smokers at 4 weeks and six months after completion of smoking cessation clinic
Time frame: Nine months (from recruitment to completion)
Subjects and controls will be reassessed at 4 weeks and six months after the last smoking cessation session to determine how many have genuinely stopped smoking. This will be confirmed at the six month follow up by measuring salivary cotinine to reveal any subjects who are being untruthful. The difference between quit rates in subjects and controls can then be calculated.
1 secondary outcome
Questionnaires to assess efficacy of Repiragene test as a motivator compared with other smoking cessation aids and motivators
Time frame: Nine months (from recruitemnt to completion)
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 14 May 2014.
- Background: PubMed 19390575Young RP, Hopkins RJ, Hay BA, Epton MJ, Mills GD, Black PN, Gardner HD, Sullivan R, Gamble GD. Lung cancer susceptibility model based on age, family history and genetic variants. PLoS One. 2009;4(4):e5302. doi: 10.1371/journal.pone.0005302. Epub 2009 Apr 23.
- Background: PubMed 19052045Smith SM, Campbell NC, MacLeod U, Lee AJ, Raja A, Wyke S, Ziebland SB, Duff EM, Ritchie LD, Nicolson MC. Factors contributing to the time taken to consult with symptoms of lung cancer: a cross-sectional study. Thorax. 2009 Jun;64(6):523-31. doi: 10.1136/thx.2008.096560. Epub 2008 Dec 3.
- Background: PubMed 19567511Sanderson SC, O'Neill SC, White DB, Bepler G, Bastian L, Lipkus IM, McBride CM. Responses to online GSTM1 genetic test results among smokers related to patients with lung cancer: a pilot study. Cancer Epidemiol Biomarkers Prev. 2009 Jul;18(7):1953-61. doi: 10.1158/1055-9965.EPI-08-0620. Epub 2009 Jun 30.
- Background: PubMed 16467073Young RP, Hopkins R, Black PN, Eddy C, Wu L, Gamble GD, Mills GD, Garrett JE, Eaton TE, Rees MI. Functional variants of antioxidant genes in smokers with COPD and in those with normal lung function. Thorax. 2006 May;61(5):394-9. doi: 10.1136/thx.2005.048512. Epub 2006 Feb 7.
- Background: PubMed 19196816Young RP, Hopkins RJ, Christmas T, Black PN, Metcalf P, Gamble GD. COPD prevalence is increased in lung cancer, independent of age, sex and smoking history. Eur Respir J. 2009 Aug;34(2):380-6. doi: 10.1183/09031936.00144208. Epub 2009 Feb 5.
- Background: PubMed 18978134Young RP, Hopkins RJ, Hay BA, Epton MJ, Black PN, Gamble GD. Lung cancer gene associated with COPD: triple whammy or possible confounding effect? Eur Respir J. 2008 Nov;32(5):1158-64. doi: 10.1183/09031936.00093908.
- Background: PubMed 19789190Young RP, Hopkins RJ, Hay BA, Epton MJ, Mills GD, Black PN, Gardner HD, Sullivan R, Gamble GD. A gene-based risk score for lung cancer susceptibility in smokers and ex-smokers. Postgrad Med J. 2009 Oct;85(1008):515-24. doi: 10.1136/pgmj.2008.077107.
- Background: PubMed 12050092McBride CM, Bepler G, Lipkus IM, Lyna P, Samsa G, Albright J, Datta S, Rimer BK. Incorporating genetic susceptibility feedback into a smoking cessation program for African-American smokers with low income. Cancer Epidemiol Biomarkers Prev. 2002 Jun;11(6):521-8.
- Background: PubMed 18420756Sanderson SC, Humphries SE, Hubbart C, Hughes E, Jarvis MJ, Wardle J. Psychological and behavioural impact of genetic testing smokers for lung cancer risk: a phase II exploratory trial. J Health Psychol. 2008 May;13(4):481-94. doi: 10.1177/1359105308088519.
- Background: PubMed 18326503Parkes G, Greenhalgh T, Griffin M, Dent R. Effect on smoking quit rate of telling patients their lung age: the Step2quit randomised controlled trial. BMJ. 2008 Mar 15;336(7644):598-600. doi: 10.1136/bmj.39503.582396.25. Epub 2008 Mar 6.
- Background: PubMed 20065338Young RP, Hopkins RJ, Smith M, Hogarth DK. Smoking cessation: the potential role of risk assessment tools as motivational triggers. Postgrad Med J. 2010 Jan;86(1011):26-33; quiz 31-2. doi: 10.1136/pgmj.2009.084947.
- Background: PubMed 10212973Soulier-Parmeggiani L, Griscom S, Bongard O, Avvanzino R, Bounameaux H. One-year results of a smoking-cessation programme. Schweiz Med Wochenschr. 1999 Mar 13;129(10):395-8.
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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.
John Nichols, MB ChB principal investigator
Surrey Primary Care Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiragene test and risk score in people with Smoking Cessation, run by Sussex NHS Research Consortium at 1 site in United Kingdom.
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 2 inclusion and 5 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 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Number of subjects versus controls who are non-smokers at 4 weeks and six months after completion of smoking cessation clinic (time frame: Nine months (from recruitment to completion)). 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 NCT01176383, which also lists 14 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 14 May 2014.