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UKLS   

Title

UK Lung Cancer Screening Trial


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Other RCT Closed RLBUHT and University of Liverpool Eudract No: N/A
Isrctn No: N/A

Purpose

United Kingdom Lung Screening trial is a large national research project which we hope will benefit people at risk of developing lung cancer. Anybody can develop lung cancer, but people who smoke (or used to smoke) are at the greatest risk. The risk increases with the total number of cigarettes you smoke. If you stop smoking, the risk gets less over time. Passive smoking (breathing in someone else's tobacco smoke) over a long period of time may also cause lung cancer. Non smokers may develop a particular type of lung cancer (called adenocarcinoma). This can happen in a part of the lung where damage has happened for a number of other reasons (such as breathing in asbestos). Lung cancer screening uses an advanced x-ray technique, called computed tomography (CT) scanning, in order to find lung cancer before symptoms develop so that early treatment can remove the cancer and deaths from lung cancer may be prevented. More people die from lung cancer in the UK every year than from any other form of cancer. About 40,000 people develop lung cancer each year in the UK and many of these are smokers. However, non-smokers and ex-smokers can also develop lung cancer. Finding lung cancer by screening instead of symptoms may mean that treatment is more effective. Lung cancer screening aims to find changes in the lung at the time of the scan but it cannot prevent you from getting lung cancer in the future. Only one randomised controlled screening trial (NLST) so far has shown that screening by CT scanning is effective. The NLST trial has been recently published and was conducted in the USA. The results showed that the mortality from lung cancer was reduced by 20%. Thus it is likely that in the same population, CT screening is effective. However, populations differ and there are other questions that remain unanswered, regarding the integration of CT screening into a national programme and which patients benefit most. The unanswered questions led a group of experts from many countries to conclude that further trials (including UKLS) were needed to answer these important questions and to guide the design of future screening programmes.


Trial Start Date

17/10/2011


Trial Coordinator

Chris Hands


Trial Coordinator Email Address

c.hands@liverpool.ac.uk


Trial Coordinator Contact No

0151 794 8244


Website Treatment  

None - This is a lung screening trial

Trial Endpoints  


Primary Outcome  

1. To establish the impact of pre-clinical detection of lung cancer mortality by comparing lung cancer mortality between the control group and the screened groups combined. 2. To establish if there is a lung cancer mortality benefit from CT screening 3. Establish total mortality benefit 4. Cost effectiveness of a national lung cancer screening programme.


Secondary Outcomes  

1. To determine the physical morbidity associated with lung cancer screening 2. To determine the resource implications of screening and the resulting intervention 3. To assess the feasibility of population screening for lung cancer as reflected by uptake of invitations and compliance rates with annual screening 4. Establish a blood and tissue bank for the future assessment of early detection diagnostics and novel tumour biomarkers

Eligibility  

Inclusion Criteria: 1. Risk criteria based on the Liverpool Lung Project Risk Prediction Model (includes age, sex, smoking duration, history of previous pneumonia, history of previous cancer, family history (early/ late onset) exposure to asbestos – algorithm 2. Males and females aged between 50 to 75 years old 3. Fully informed written consent given Exclusion Criteria: 1. Unable to give consent 2. Co-morbidity which would unequivocally contra-indicate either screening or treatment if lung cancer were detected. 3. A CT scan of the chest performed within one year of the invitation to be screened. 4. Any condition precluding written informed consent 5. Inability to lie flat 6. Weight greater than 200 kg (too large for CT scanner)