Manchester Lung Health Study

Study Overview
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Brief Summary
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The Manchester Lung Health Study (qUEST) will assess the uptake of a community-based lung cancer screening service and its impact across a deprived area of North and East Manchester, which has high rates of lung cancer. One measure will be to compare the number and stage of lung cancers detected through screening to those detected outside of screening. In addition we will investigate the potential of a blood and nose test to detect lung cancer or to help decide who would benefit from screening. We will also see if these samples can help with the interpretation of CT scans. One of the problems with lung cancer CT screening is that you detect lung nodules in which we are not sure if they are benign or cancerous. Therefore we are also looking to see if a biomarker can help us work out which are cancerous and which are benign.

Official Title
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An Observational Cohort Study Investigating the Impact of Community-based Lung Cancer Screening Across a Deprived Geographical Area and the Role of Biomarkers for the Early Detection of Lung Cancer.

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Lung Cancer Screening
* Diagnostic Test: Biomarkers


Participation Criteria
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Eligibility Criteria
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Main data study: Inclusion Criteria: - Any individual attending the Manchester Lung Health service who has a lung health check as they meet the service inclusion exclusion criteria (see below): Manchester Lung Health service inclusion criteria: Age 55-80 Ever smoker Registered with a GP in the North or East Manchester area Manchester Lung Health service exclusion Criteria: Lung cancer diagnosis within 5 years Listed on a palliative care register Chest CT scan within 3 months Exclusion Criteria: - Unable to give informed consent to study participation. Biomarker sub-study: Inclusion Criteria: Any individual attending the M-LHC service who is eligible and agrees to undergo LDCT screening. Has consented to the main study. Exclusion Criteria: Unable to give informed consent to study participation Decline participation in LDCT lung cancer screening Known blood borne virus e.g. HIV or Hepatitis B, C

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Data (main study)<br>This study group is for any individual that attends and has a lung health check. The data collected for this study group is to evaluate the uptake and performance of a community-based lung health check / lung screening programme. | Diagnostic Test: Lung Cancer Screening<br>* The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)<br>|
| Biomarker (sub-study)<br>This sub-study is for participants that are determined to require a CT scan through their lung health check and have also signed up to the data part of the study. This part of the study is to evaluate the potential for biomarkers to improve the early detection of lung cancer. | Diagnostic Test: Lung Cancer Screening<br>* The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)<br>Diagnostic Test: Biomarkers<br>* This will explore the role of biomarkers for the early detection of lung cancer. These include circulating nucleic acids, circulating proteins, circulating tumour cells and inflammatory markers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of the Manchester lung health check service | The overall uptake will be assessed and analysed according to age, sex, smoking status, ethnicity and socio economic status. | Over 3 years to determine long term outcomes from screening | 
| Evaluation of biomarkers | Sensitivity and specificity of a biomarker or panel of biomarkers to detect early stage lung cancer. | Over 3 years to determine long term outcomes from screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening adherence | overall and according to patient characteristics (age, sex, smoking status, ethnicity and socio economic status). | Over 3 years to determine long term outcomes from screening | 
| Evaluation of screening numbers required to detect lung cancer | Number needed to screen to detect one lung cancer according to lung cancer risk (as calculated by PLCOM2012). | Over 3 years to determine long term outcomes from screening | 
| Comparison between cohort and those residents diagnosed in north and east manchester | Lung cancer stage in the screened cohort compared to lung cancers diagnosed in residents of N+EM outside of the screening service. | Over 3 years to determine long term outcomes from screening | 
| Histological subtype for lung cancer related to screening service | Histological subtype of lung cancers in screening and outside of screening during the course of the service. | Over 3 years to determine long term outcomes from screening | 
| Treatment for lung cancer related to screening service | Treatment of lung cancers in screening and outside of screening during the course of the service. | Over 3 years to determine long term outcomes from screening | 
| Diagnosis route for lung cancer related to screening service | Route to diagnosis of lung cancers in screening and outside of screening during the course of the service. | Over 3 years to determine long term outcomes from screening | 
| False positive rates | False positive rates in those undergoing LDCT screening. | Over 3 years to determine long term outcomes from screening | 
| False negative rates | False negative rates in those undergoing LDCT screening. | Over 3 years to determine long term outcomes from screening | 
| Rates of investigation of benign disease | Rates of investigation of benign disease in those undergoing LDCT screening. | Over 3 years to determine long term outcomes from screening | 
| Benign resection rate in participants | Benign resection rate in participants for those that have undergoing LDCT screening. | Over 3 years to determine long term outcomes from screening | 
| Interval cancers | Interval cancers in those undergoing LDCT screening. | Over 3 years to determine long term outcomes from screening | 
| Recall rates | Recall rates in those undergoing LDCT screening. | Over 3 years to determine long term outcomes from screening | 
| Resection rates generated from screening | Resection rates generated from screening including incidental findings. | Over 3 years to determine long term outcomes from screening | 
| Investigations generated from screening | Investigations generated from screening including incidental findings. | Over 3 years to determine long term outcomes from screening | 
| Adverse events generated from screening | Adverse events generated from screening including incidental findings. | Over 3 years to determine long term outcomes from screening | 
| Assessment of the British Thoracic Society pulmonary nodule guidelines | Assessment of performance of the BTS pulmonary nodules guideline in the setting of screening service. | Over 3 years to determine long term outcomes from screening | 
| Smoking prevalence | Smoking prevalence and amount at the start and end of screening. | Over 3 years to determine long term outcomes from screening | 
| Undiagnosed airflow obstruction | Prevalence of undiagnosed airflow obstruction in the screened population. | Over 3 years to determine long term outcomes from screening | 
| Coronary artery calcification | Prevalence of coronary artery calcification and QRISK2 score. | Over 3 years to determine long term outcomes from screening |