Clinical trial NCT04409444: Manchester Lung Health Study
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Cancer Research UK
name: University of Manchester
First posted: 2020-06-01
Enrollment: 9730
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Uptake of the Manchester lung health check service
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Evaluation of biomarkers
timeFrame: Over 3 years to determine long term outcomes from screening
Secondary outcomes:
measure: Screening adherence
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Evaluation of screening numbers required to detect lung cancer
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Comparison between cohort and those residents diagnosed in north and east manchester
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Histological subtype for lung cancer related to screening service
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Treatment for lung cancer related to screening service
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Diagnosis route for lung cancer related to screening service
timeFrame: Over 3 years to determine long term outcomes from screening
measure: False positive rates
timeFrame: Over 3 years to determine long term outcomes from screening
measure: False negative rates
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Rates of investigation of benign disease
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Benign resection rate in participants
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Interval cancers
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Recall rates
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Resection rates generated from screening
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Investigations generated from screening
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Adverse events generated from screening
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Assessment of the British Thoracic Society pulmonary nodule guidelines
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Smoking prevalence
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Undiagnosed airflow obstruction
timeFrame: Over 3 years to determine long term outcomes from screening
measure: Coronary artery calcification
timeFrame: Over 3 years to determine long term outcomes from screening
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Trust
Study officials:
affiliation: Manchester University NHS Trust
name: Philip Crosbie
role: PRINCIPAL_INVESTIGATOR
References: