Lung Cancer Screening Study Using Low Dose CT With Development and Evaluation of the GRAIL Test. — SUMMIT  

Lung Cancer Clinical Trial

Official title: Lung Cancer Screening Study Using Low Dose CT With Development and Evaluation of the GRAIL Test.

Status Not yet recruiting

Clinical Trial Summary

This study has two main aims. The first one is to examine how to deliver a lung cancer screening service in North Central and North East London and Essex.

At the moment, the best way of finding early lung cancer is a special type of x-ray called a low dose Computed Tomography (LDCT) scan. LDCT screening is currently available in the USA to those at higher risk of getting lung cancer. The second aim of this study is to develop a blood test to find lung cancer at an early stage, when it is usually curable. This blood test may also be used to find other types of cancer in the future.

Clinical Trial Description

One of the aims of this study is to introduce Low dose CT scan (LDCT) screening for smokers/ex-smokers between the ages of 55 and 80. In order to do this, the study will look to include 250000 participants. Potential participants will be flagged by their GP (general practitioner) as they meet the requirements of being between 55 and 80 and are current smokers/ex-smokers. They will be sent an invitation to a lung health check, where they will have spirometry to assess lung capacity (any findings at this stage will be sent to the GP, if the person agrees). At this lung health check a nurse will talk to them about taking part in the study. They will have time to read through the participant information sheet, and if they are interested in taking part they have the option of signing the consent form on the same day, or scheduling an appointment for a later date.

Once they have signed the consent form, participants will need to undergo an eligibility check, will have a blood test, a low-dose CT scan (LDCT) and will complete some questionnaires. Participants will be expected to come in once every year for 3 years at a minimum (depending on the results of the scan). Participants will be randomised either to having a LDCT scan at each of these 3 visits, or having 2 LDCT scans, one at the baseline visit and one at the year 3 visit. This will be randomly allocated at the beginning of the year 2 visit. At each follow up visit to the clinic the participant will have a blood test, a LDCT scan and will complete some questionnaires. The LDCT scans will be analysed to see the difference between yearly scans, or a scan every two years. LDCT scans are expensive, and it may be more cost-effective to try to introduce screening every two years for high-risk individuals.

Participants may be referred to their local hospital if there are any significant findings on their scan, and if these findings are found to be cancer the participant will no longer take part in the trial. Some LDCT scans may show other findings, which will not be sent straight to the participants' local hospital as they are not significant. In these cases, either a letter will be sent to their GP (general practitioner) explaining the findings, or they will be asked to come back to the clinic for a scan 3 months later to have another LDCT scan.

Radiologist who will analyse the LDCT scans will have to undergo a quality assurance and audit, to avoid any researcher bias/ researcher effects. ;

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

• NCT number: NCT03337685
• Study type: Observational
• Source: University College, London
• Contact: Anne Marie Mullin
• Phone: 02076799872
• Email: ctc.summit@ucl.ac.uk
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2018
• Completion date: December 2026