Manchester Lung Health Study

Lung Cancer Clinical Trial

— qUEST  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04409444
• Other study ID #: B00212
• Secondary ID: 252263 (IRAS)19/
• Status: Recruiting
• Start date: August 20, 2019
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2023
• Source: Manchester University NHS Foundation Trust
• Contact: Philip Crosbie
• Phone: 01612912116
• Email: philip.crosbie[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9730
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• Lung Cancer Screening
The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)
• Biomarkers
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.

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Trust	Manchester

Sponsors (3)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	Cancer Research UK, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	False positive rates	False positive rates in those undergoing LDCT screening.	Over 3 years to determine long term outcomes from screening
Secondary	False negative rates	False negative rates in those undergoing LDCT screening.	Over 3 years to determine long term outcomes from screening
Secondary	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
Secondary	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
Secondary	Interval cancers	Interval cancers in those undergoing LDCT screening.	Over 3 years to determine long term outcomes from screening
Secondary	Recall rates	Recall rates in those undergoing LDCT screening.	Over 3 years to determine long term outcomes from screening
Secondary	Resection rates generated from screening	Resection rates generated from screening including incidental findings.	Over 3 years to determine long term outcomes from screening
Secondary	Investigations generated from screening	Investigations generated from screening including incidental findings.	Over 3 years to determine long term outcomes from screening
Secondary	Adverse events generated from screening	Adverse events generated from screening including incidental findings.	Over 3 years to determine long term outcomes from screening
Secondary	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
Secondary	Smoking prevalence	Smoking prevalence and amount at the start and end of screening.	Over 3 years to determine long term outcomes from screening
Secondary	Undiagnosed airflow obstruction	Prevalence of undiagnosed airflow obstruction in the screened population.	Over 3 years to determine long term outcomes from screening
Secondary	Coronary artery calcification	Prevalence of coronary artery calcification and QRISK2 score.	Over 3 years to determine long term outcomes from screening