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.
3 other identifiers
observational
9,730
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2019
CompletedFirst Submitted
Initial submission to the registry
May 21, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedMay 31, 2023
May 1, 2023
5 years
May 21, 2020
May 30, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (19)
Screening adherence
Over 3 years to determine long term outcomes from screening
Evaluation of screening numbers required to detect lung cancer
Over 3 years to determine long term outcomes from screening
Comparison between cohort and those residents diagnosed in north and east manchester
Over 3 years to determine long term outcomes from screening
Histological subtype for lung cancer related to screening service
Over 3 years to determine long term outcomes from screening
Treatment for lung cancer related to screening service
Over 3 years to determine long term outcomes from screening
- +14 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)
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.
Eligibility Criteria
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.
You may not qualify if:
- Age 55-80
- Ever smoker
- Registered with a GP in the North or East Manchester area
- 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:
- Any individual attending the M-LHC service who is eligible and agrees to undergo LDCT screening.
- Has consented to the main study.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Manchester University NHS Foundation Trustlead
- Cancer Research UKcollaborator
- University of Manchestercollaborator
Study Sites (1)
Manchester University NHS Trust
Manchester, United Kingdom
Biospecimen
A blood sample of up to 50mL will be taken from participants for analysis of circulating tumour cells, circulating nucleic acid, proteins and genetic variations (single nucleotide polymorphisms). Nasal swab and brush samples will be taken for the identification of inflammatory markers.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Crosbie
Manchester University NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2020
First Posted
June 1, 2020
Study Start
August 20, 2019
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
May 31, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
Only fully anonymised data will be sent to collaborating researchers