Genetic test to stop smoking (GeTSS) trial protocol: randomised controlled trial of a genetic test (Respiragene) and Auckland formula to assess lung cancer risk.

BACKGROUND

A gene-based estimate of lung cancer risk in smokers has been shown to act as a smoking cessation motivator in hospital recruited subjects. The objective of this trial is to determine if this motivator is as effective in subjects recruited from an NHS primary care unit.

METHOD/DESIGN: Subjects will be recruited by mailings using smoking entries on the GP electronic data-base (total practice population = 32,048) to identify smokers who may want to quit. Smoking cessation clinics based on medical centre premises will run for eight weeks. Clinics will be randomised to have the gene-based test for estimation of lung cancer risk or to act as controls groups. The primary endpoint will be smoking cessation at eight weeks and six months. Secondary outcomes will include ranking of the gene-based test with other smoking cessation motivators.

DISCUSSION

The results will inform as to whether the gene-based test is both effective as motivator and acceptable to subjects recruited from primary care.

TRIAL REGISTRATION

Registered with Clinical Trials.gov,

REGISTRATION NUMBER

NCT01176383.