Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Smoking Cessation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Respiragene test and risk score | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- The control group will have a standard NHS cessation clinic experience
- type
- EXPERIMENTAL
- label
- Respiragene test and risk score
- description
- 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.
- interventionNames
- Genetic: Respiragene test and risk score
Primary outcomes (1)
- measure
- Number of subjects versus controls who are non-smokers at 4 weeks and six months after completion of smoking cessation clinic
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (14)
- BACKGROUNDYoung 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. PMID 19390575
- BACKGROUNDSmith 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. PMID 19052045
- BACKGROUNDSanderson 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. PMID 19567511
- BACKGROUNDYoung 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. PMID 16467073
- BACKGROUNDYoung 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. PMID 19196816
- BACKGROUNDYoung 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. PMID 18978134
- BACKGROUNDYoung 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.