Manchester Lung Health Study
- Conditions
- Lung Cancer
- Interventions
- Diagnostic Test: Lung Cancer ScreeningDiagnostic Test: Biomarkers
- Registration Number
- NCT04409444
- Lead Sponsor
- Manchester University NHS Foundation Trust
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9730
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Biomarker (sub-study) Biomarkers 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. Data (main study) Lung Cancer Screening 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. Biomarker (sub-study) Lung Cancer Screening 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.
- Primary Outcome Measures
Name Time Method Evaluation of biomarkers Over 3 years to determine long term outcomes from screening Sensitivity and specificity of a biomarker or panel of biomarkers to detect early stage lung cancer.
Uptake of the Manchester lung health check service Over 3 years to determine long term outcomes from screening The overall uptake will be assessed and analysed according to age, sex, smoking status, ethnicity and socio economic status.
- Secondary Outcome Measures
Name Time Method Screening adherence Over 3 years to determine long term outcomes from screening overall and according to patient characteristics (age, sex, smoking status, ethnicity and socio economic status).
Treatment for lung cancer related to screening service Over 3 years to determine long term outcomes from screening Treatment of lung cancers in screening and outside of screening during the course of the service.
False positive rates Over 3 years to determine long term outcomes from screening False positive rates in those undergoing LDCT screening.
Recall rates Over 3 years to determine long term outcomes from screening Recall rates in those undergoing LDCT screening.
Investigations generated from screening Over 3 years to determine long term outcomes from screening Investigations generated from screening including incidental findings.
Adverse events generated from screening Over 3 years to determine long term outcomes from screening Adverse events generated from screening including incidental findings.
Smoking prevalence Over 3 years to determine long term outcomes from screening Smoking prevalence and amount at the start and end of screening.
Comparison between cohort and those residents diagnosed in north and east manchester Over 3 years to determine long term outcomes from screening Lung cancer stage in the screened cohort compared to lung cancers diagnosed in residents of N+EM outside of the screening service.
Evaluation of screening numbers required to detect lung cancer Over 3 years to determine long term outcomes from screening Number needed to screen to detect one lung cancer according to lung cancer risk (as calculated by PLCOM2012).
False negative rates Over 3 years to determine long term outcomes from screening False negative rates in those undergoing LDCT screening.
Coronary artery calcification Over 3 years to determine long term outcomes from screening Prevalence of coronary artery calcification and QRISK2 score.
Histological subtype for lung cancer related to screening service Over 3 years to determine long term outcomes from screening Histological subtype of lung cancers in screening and outside of screening during the course of the service.
Interval cancers Over 3 years to determine long term outcomes from screening Interval cancers in those undergoing LDCT screening.
Resection rates generated from screening Over 3 years to determine long term outcomes from screening Resection rates generated from screening including incidental findings.
Assessment of the British Thoracic Society pulmonary nodule guidelines Over 3 years to determine long term outcomes from screening Assessment of performance of the BTS pulmonary nodules guideline in the setting of screening service.
Diagnosis route for lung cancer related to screening service Over 3 years to determine long term outcomes from screening Route to diagnosis of lung cancers in screening and outside of screening during the course of the service.
Rates of investigation of benign disease Over 3 years to determine long term outcomes from screening Rates of investigation of benign disease in those undergoing LDCT screening.
Benign resection rate in participants Over 3 years to determine long term outcomes from screening Benign resection rate in participants for those that have undergoing LDCT screening.
Undiagnosed airflow obstruction Over 3 years to determine long term outcomes from screening Prevalence of undiagnosed airflow obstruction in the screened population.
Trial Locations
- Locations (1)
Manchester University NHS Trust
🇬🇧Manchester, United Kingdom