Impact of a Gene Test for Susceptibility to Lung Cancer in Smokers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Surrey.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Lab 21, Cambridge
NHS Research and Development
Information provided by (Responsible Party):
John A A Nichols, University of Surrey
ClinicalTrials.gov Identifier:
NCT01176383
First received: August 3, 2010
Last updated: March 3, 2012
Last verified: March 2012

August 3, 2010
March 3, 2012
September 2011
October 2012   (final data collection date for 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) ] [ Designated as safety issue: No ]
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.
Number of subjects who have quit smoking at 4 weeks and six months after completion of smoking cessation clinic [ Time Frame: Completion at 9 months after last smoking cessation session ] [ Designated as safety issue: No ]
All subjects will be reassessed at 4 weeks and nine months after the last smoking cessation session to determine how many have genuinely stopped smoking. This will be confirmed by measuring salivary cotinine to reveal any subjects who are being untruthful.
Complete list of historical versions of study NCT01176383 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: No ]
All subjects will be asked to complete questionnaires (with assistance as needed) to asess the percived 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 ctinine, spirometry results etc.)
Questionnaires to assess efficacy of Repiragene test as a motivator compared with other smoking cessation aids and motivators [ Time Frame: Completion at 9 months after last smoking cessation session ] [ Designated as safety issue: No ]
All subjects will be asked to complete questionnaires (with assistance as needed) to asess the percived 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 ctinine, spirometry results etc.)
Not Provided
Not Provided
 
Impact of a Gene Test for Susceptibility to Lung Cancer in Smokers
A Protocol for an RCT 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 NHS 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.

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 FH 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, UK. 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 Respitagene 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 SPSS Statistics 17.0 computer programme.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Smoking Cessation
Other: Respiragene test
This 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
Other Name: Respiragene tes, Lab 21, cambridge
  • No Intervention: Standard NHS smoking cessation
    The control group will have a standard NHS smoking cessation clinic experience of eight weekly smoking cessation sessions with counseling, the carbon monoxide breath test, salivary cotinine test and prescription of smoking cessation aids where appropriate (i.e. varenicline) but they will NOT have the added intervention of the Respiragene test.
    Intervention: Other: Respiragene test
  • Smoking cessation + Respiragene test
    This is the intervention group who, in addition to the same standard NHS smoking cessation clinic experience of the controls WILL have the Respiragene test with individual counselling on the results and their estimated lifetime risk of lung cancer.
    Intervention: Other: Respiragene test

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
October 2012
October 2012   (final data collection date for primary outcome measure)

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.

Both
20 Years to 70 Years
Yes
Contact: John AA Nichols, MB, ChB (0)1483564967 drjaan@ntlworld.com
Contact: Paul Grob, MD (0)1483810410 paul.grob1@btinternet.com
United Kingdom
 
NCT01176383
SPCRU1
Yes
John A A Nichols, University of Surrey
University of Surrey
  • Lab 21, Cambridge
  • NHS Research and Development
Principal Investigator: John Nichols, MB ChB Surrey Primary Care Research Unit
University of Surrey
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP