The Lung Health Check Pilot

NCT07099027 | Recruiting DMC

• 1 other identifier: LHC Pilot
• Study Type: interventional
• Target: 2,183
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Screening; Lung cancer

Outcome Measures

Primary Outcomes (2)

• 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

  1 year

• 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

  1 year

Secondary Outcomes (27)

• 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)

  2 years

• 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

  1 year

• The proportion of high-risk eligible participants aged 55-74 years for whom an appointment is booked in a community-based LHC visit

  1 year

• The proportion of high-risk participants that attend from an urban versus rural setting.

  1 year

• The proportion of high-risk participants that respond to the LHC invitation and are deemed eligible by age, gender, socioeconomic status, social deprivation index, and presence of co-morbid conditions

  1 year

Study Arms (1)

Lung Health Check

EXPERIMENTAL

In this arm, consented participants will undergo a 'Lung Health Check' which incorporates a respiratory disease assessment, smoking cessation, low-dose CT and collection of biospecimens for translational analyses.

Diagnostic Test: Low dose CT

Interventions

Low dose CT DIAGNOSTIC_TEST

In this arm, participants will undergo a respiratory assessment, smoking cessation, low-dose CT and biospecimen for translational research.

Lung Health Check

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Referred from a GP for the LHC pilot
• PLCOM2012 ≥ 1.51% or LLPv2 ≥2.5% (Lung Cancer Risk Scores)
• Prostate Lung Cancer Colorectal Ovarian (PLCO) \& Liverpool Lung Project Version 2 (LLPv2)

You may not qualify if:

• 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
• Likely non-compliance with study procedures, as determined by the participant i) Unable to provide informed consent ii) Inability to attend study visits
• Nursing home residents -

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Beaumont RCSI Cancer Centre

Dublin, Ireland

RECRUITING

Related Publications (1)

• O Reilly D, Roche S, Noonan C, O'Shea J, Toomey S, Hennessy BT, Fitzmaurice GJ, Egan K, Dunne J, Dowling CM, Counihan I, O'Brien E, Sulaiman I, Morgan R, Jacob B, Baird AM, Cotter S, Bailey D, Maguire G, Bennett K, Sorensen J, Healy NA, Ryan J, Redmond P, Ryan DJ, Naidoo J. Lung Health Check pilot: Ireland's flagship lung cancer screening trial. BMJ Open Respir Res. 2025 Sep 10;12(1):e003035. doi: 10.1136/bmjresp-2024-003035.

  PMID: 40935563 DERIVED

Related Links

• Lung Heath Check website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jarushka Naidoo, MD

  Beaumont RCSI Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Roche, PhD

CONTACT

018093010; lunghealthcheck@beaumont.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: August 1, 2025
• Study Start: May 19, 2025
• Primary Completion: February 15, 2026
• Study Completion (Estimated): January 15, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)