- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01176383
Impact of a Gene Test for Susceptibility to Lung Cancer in Smokers
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Surrey
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Epsom, Surrey, United Kingdom, KT17 4BL
- The Integrated Care Partnership The Old Cottage Hospital Alexandra Road,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 20-70 years
- Smoking more than 10 cigarettes daily
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control group
The control group will have a standard NHS cessation clinic experience
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Experimental: Respiragene test and risk score
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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Nine months (from recruitment to completion)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.)
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Nine months (from recruitemnt to completion)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Nichols, MB ChB, Surrey Primary Care Research Unit
Publications and helpful links
General Publications
- Parkes 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.
- 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.
- Smith 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.
- Sanderson 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.
- Young 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.
- Young 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.
- Young 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.
- Young 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.
- McBride 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.
- Sanderson 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.
- Young 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.
- Soulier-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.
- Nichols 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.
- Nichols 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPCRU1
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