Manchester Lung Health Study (qUEST)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: Lung Cancer Screening; Diagnostic test: Biomarkers

• Study Type: Observational
• Enrollment (Estimated): 9730

Contacts and Locations

• Study Contact: Name: Philip Crosbie; Phone Number: 01612912116; Email: philip.crosbie@manchester.ac.uk
• Study Contact Backup: Name: Sara Waplington; Phone Number: 01612912835; Email: sara.waplington@mft.nhs.uk

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • Recruiting
    • Manchester University NHS Trust
    • Contact: Philip Crosbie; Phone Number: 01612912116; Email: philip.crosbie@manchester.ac.uk
    • Contact: Sara Waplington; Phone Number: 01612912835; Email: sara.waplington@mft.nhs.uk
    • Principal Investigator: Philip Crosbie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Individuals will be attending a lung health check as they are registered to a GP practice in north and east Manchester, between the ages of 55-80 and an ever smoker.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Data (main study); 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; The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)
Biomarker (sub-study); 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; The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model); Diagnostic test: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Cancer Research UK; University of Manchester
• Investigators: Principal Investigator: Philip Crosbie, Manchester University NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: B00212; 252263 (IRAS) (Other Identifier: Health Research Authority); 19/LO/0404 (REC) (Other Identifier: Health Research Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only fully anonymised data will be sent to collaborating researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No