Please select the eligibility criteria that correspond to the clinical trial below.
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
Brief 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 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.


Options:
A: Inclusion Criteria:

* Active smoker

Exclusion Criteria:

* Enrollment in smoking cessation protocol
* Current use of nicotine replacement therapy
B: Inclusion Criteria:

- Active smokers over 40 years and more than 10 pack-years

Exclusion Criteria:

* Previous diagnosis of respiratory disease (asthma, COPD, interstitial lung disease) that cause alteration of spirometric pattern.
* Patients with limitations in performing spirometry
* Age greater than 80 years
* Institutionalized patients
* Patients with a life expectancy less than 1 year
* Spirometry in the past 2 years
C: Inclusion Criteria:

* Enrolled in a Durham VA Primary Care Clinic for at least one year
* Age ≥ 55 years old
* Diagnosis ICD 401.0, 401.1, or 401.9 on outpatient electronic encounter forms in the prior year
* Received a prescription for hypertensive medication (ACE inhibitors, beta blockers, calcium channel blockers, diuretics, alpha1 blockers, and/or central alpha2 agonists) in the previous year
* Inadequate BP control based on an average of prior 12-month clinic BP measurements
* Have a baseline EKG within the last 5 years to evaluate the presence of left ventricular hypertrophy.

Exclusion Criteria:

* Hospitalized at the DVAMC for a myocardial infarction (MI), coronary artery revascularization, or diagnosis of metastatic cancer in the past 6 months
* Prior history of stroke
* Active diagnosis of psychosis or dementia documented in medical record
* Participating in another chronic disease self-management study
* Resident of a nursing home
* Does not have access to a telephone
* Refusal to provide informed consent
D: 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.

Answer: D