Title: United Kingdom Lung Cancer Screening Trial (UKLS) - Pilot
Funder: Department of Health (England)

Abstract: Design: To develop a multicentre randomised controlled lung cancer screening trial comparing CT screened individuals to a non-screened group of high-risk individuals 50 -75 years of age.Setting: Pilot & Main trial -high risk population in the vicinity of UK thoracic centre’s specialising in lung cancer imaging pathology and surgery.Target population: Pilot & Main trial - Individuals identified as high risk from questionnaire sent out to 50-75 year olds in specific areas of the UK (Liverpool H&CH & Papworth Hospital) through their local PCTs. All individuals who are recruited will fulfill the inclusion criteria as detailed in the UKLS protocol.Health technologies being assessed:This trial aims to examine the use of 16 channel (or higher) multidetector CT (MDCT) in the screened group to identify early lung ca.Measurement of costs and outcomes: The major outcome measure of the UKLS Pilot is to provide the required data on which to base the criteria to proceed to Main Trial: (i) to proceed to the Main Trial (ii) adapt the recruitment or Protocol for the Main trial or (iii) to stop the UKLS Trial. The proposed outcomes in the UKLS Pilot Trial are1. Response rate to initial questionnaire2. Proportion of initial responders who are eligible3. Proportion of eligible subjects agreeing to participate4. Compliance rate with screening in those consenting and randomised to the intervention arm5. Weekly rate of delivery of screening in the pilot centres6. Proportion of screenees marked for further diagnostic investigationWe shall also monitor the performance of all aspects of the clinical care pathway and the research evaluation technicalities including for example the database system. Response and completion rates of health economic and psychosocial questionnaires will also be measured to feed into the main trial. The main trial outcomes will be specified in the full proposal for the main trial but in summary the main trial primary outcome will be lung cancer mortality. There will be a number of secondary outcomes including: Lung cancer incidence; Early stage disease incidence; Economic outcomes including cost effectiveness; All-cause mortality; Screening quality markers; Clinically harmful effects of screening diagnosis and treatment; Psychosocial and quality of life benefits and harms; Smoking stopping and relapsing rates.Sample size:*UKLS Pilot Study: The Wald Single Screen Design in which the study arm is offered a single CT scan (with appropriate further workup where necessary) the control arm is given usual care has been chosen for the UKLS trial. A high-risk population will be approached in the pilot trial (82000) using a two stage questionnaire of these 4000 will be recruited.The main UKLS trial will approach 682000 individuals with the two stage questionnaire with a total of 32000 participants recruited. We have already calculated that 16000 in each trial arm with one round of screening in the intervention arm and 10 years of follow-up will give around 90% power for a 25-30% mortality reduction in a high risk group with annual incidence of 5 per 1000 per year. All UKLS participants will be followed up for 10 years using Cancer Registry and ONS databases.


Research activity codes: 4.4 POPULATION SCREENING
Health categories: CANCER AND NEOPLASMS