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

Lung Cancer Clinical Trial

— SUMMIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03337685
• Other study ID #: UCL/17/0050
• Status: Not yet recruiting
• Phase: N/A
• First received: October 12, 2017
• Last updated: November 6, 2017
• Start date: June 2018
• Est. completion date: December 2026

Study information

• Verified date: October 2017
• Source: University College, London
• Contact: Anne Marie Mullin
• Phone: 02076799872
• Email: ctc.summit[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25000
• Est. completion date: December 2026
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

• 1.Individuals 55 to 80 years old who meet either of the following criteria: a .USPSTF LDCT screening criteria:a history of at least 30 pack years of smoking (or at least 20 years duration), and if former smokers, have quit in the past 15 years b. PLCOm2012 (risk prediction model) 6-year lung cancer risk of =1.3%.

• 2.The individual has been informed of the nature of the study, agrees to its provisions and has provided written informed consent

• 3.Willingness to participate in all visits, required scans, and long-term follow-up, preferably via the internet (e.g. emailed requests for further self-reported information regarding cancer diagnoses, change to health plan or residential status, or request for serial blood draws)

Exclusion Criteria:

• History of CT chest for any reason within 18 months of enrollment.

• Inability on the part of the participant to understand the informed consent process or unwilling to comply to the study protocol

• On chemotherapy or radiotherapy for an active malignancy

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• Low dose CT Scan
Low dose CT scans

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	GRAIL, Inc., UCLH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung cancer incidence (including screen detected, delayed screen detected and interval cancers)	collected from LDCT scans, referrals and from follow up data collected from registries	Eight and a half years
Secondary	Smoking cessation	Assessing changes in smoking behaviours among smokers	3 and a half years
Secondary	Smoking status	Assessing changes in smoking status among smokers	3 and a half years
Secondary	Intention to quit smoking	Assessing intentions to quit among smokers	3 and a half years
Secondary	The GRAIL blood test for lung cancer diagnosis (following LDCT) and screening.	The GRAIL blood marker for lung cancer screening is undergoing preliminary scientific development within the Circulating Cell-Free Genome Atlas (CCGA) study (identifier: NCT02889978).The marker will be refined specifically for lung cancer as part of SUMMIT.	Eight and a half years