The Lung Health Check Pilot
ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-74
SponsorRoyal College of Surgeons, Ireland
About this trial
This study aims to test if it is feasible to introduce lung cancer screening in Ireland.
People within a certain age group, who smoke or who smoked in the past, are at a greater risk of developing lung cancer. They can also develop chronic lung conditions that can affect their long-term health. In Ireland, about 2,690 people are diagnosed with Lung Cancer every year. Unfortunately, 2 out of every 3 people diagnosed with lung cancer die per year.
The goal of this study is to try to screen for lung cancer in people before they have symptoms associated with the disease. We aim to do this by selecting people based on their age, whether they have smoked in the past or currently smoke as well as other relevant factors. People who take part in this study will have an assessment of how their lungs work and a low-dose CT scan. This is called a lung health check. The goal of the low-dose CT scan is to pick up lung cancer before it becomes symptomatic, and at an earlier stage. This scan uses a very low dose of radiation.
Unfortunately, without early detection, such as is the goal of this trial, 8 out of 10 people who go on to develop lung cancer will have advanced lung cancer when it is discovered, where outcomes tend to be poor. The earlier detection of lung cancer has a greater potential for treatment. Current international recommendations suggest carrying out these scans in the community rather than in a hospital. Therefore, we aim to deliver these lung health checks using a mobile unit in the community.
This study aims to test if we will successfully pick up lung cancer earlier by doing community-based 'lung health check's using mobile units in North Dublin and the North East, among people of a certain age and smoking history.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
55 - 74 years of age
Current or former smokers
Current: >100 cigarettes in lifetime and/or currently tobacco smoking
Former: >100 cigarettes in lifetime and/or no tobacco smoking >= 28 days
Disqualifiers
Participant-reported history of chest CT in the last 12 months
Inability to undergo non-contrast CT (e.g. >200 kg body weight, inability to lie flat)
Participant reported known diagnosis of other advanced stage cancers
Participant reported diagnosis of lung cancer of any stage in the last 5 years
Trial design
Design model
Single group
Treatments tested in this trial
Low dose CT
Diagnostic testIn this arm, participants will undergo a respiratory assessment, smoking cessation, low-dose CT and biospecimen for translational research.
Treatment groups
2,183 Participants
are divided into 1 treatment groupGroup A: Lung Health CheckExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
i) The proportion of high-risk eligible participants aged 55-74 years who participate in a community-based lung health check ii)The proportion of individuals who consent to undergo telephone assessment
i) Number of eligible participants who attend the LHC pilot after GP invitation/Number of high-risk participants invited via GP letter to the LHC pilot ii) Number of participants who consent to undergo telephone assessment/number of participants invite via GP letter to LHC pilot
Time frame
1 year2
The proportion of individuals who consent to undergo telephone assessment
Number of individuals who consent to undergo telephone assessment/Number of individuals invited via GP letter to the LHC pilot ii) Number of participants who consent to undergo telephone assessment/number of participants invite via GP letter to LHC pilot
Time frame
1 yearSecondary outcomes
1
The proportion of the participants (aged 55-74 years, from catchment area, who receive GP invitation) who attend a community-based initial (T0)LHC visit, and the mandated follow-up visit (T1)
The proportion of the participants (aged 55-74 years, from catchment area, who receive GP invitation) who attend a community-based initial (T0)LHC visit, and the mandated follow-up visit (T1)
Time frame
2 years2
The proportion of participants (aged 55-74 years, from catchment area, who receive GP invitation) who attend a community-based T0 LHC visit, that are deemed eligible to participate based on eligibility criteria and risk scores
The proportion of participants (aged 55-74 years, from catchment area, who receive GP invitation) who attend a community-based T0 LHC visit, that are deemed eligible to participate based on eligibility criteria and risk scores
Time frame
1 year3
The proportion of high-risk eligible participants aged 55-74 years for whom an appointment is booked in a community-based LHC visit
The proportion of high-risk eligible participants aged 55-74 years for whom an appointment is booked in a community-based LHC visit
Time frame
1 year4
The proportion of high-risk participants that attend from an urban versus rural setting.
The proportion of high-risk participants that attend from an urban versus rural setting.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov