Lung CancerqUESTNCT04409444
Manchester Lung Health Study
An observational study of Lung Cancer, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Lung Cancer Screening and Biomarkers
- How many people
- 9,730 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Aug 2019to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 11Show fewer
- Lung cancer diagnosis within 5 years
- Listed on a palliative care register
- Chest CT scan within 3 months
- Any individual attending the M-LHC service who is eligible and agrees to undergo LDCT screening.
- Has consented to the main study.
Who cannot join
- Unable to give informed consent to study participation.
- Biomarker sub-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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester University NHS Trust
Manchester
Philip Crosbie, 01612912116, philip.crosbie@manchester.ac.uk
Sara Waplington, 01612912835, sara.waplington@mft.nhs.uk
About this 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.
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.
- Conditions
- Lung Cancer
- Being tested
- Lung Cancer Screening, Biomarkers
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Cancer ScreeningDiagnostic test
The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)
BiomarkersDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Lung Cancer Screening | |
| 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. Receives: Diagnostic Test: Lung Cancer Screening; Diagnostic Test: Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Over 3 years to determine long term outcomes from screening
Secondary outcomes (19)
Screening adherence
overall and according to patient characteristics (age, sex, smoking status, ethnicity and socio economic status).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Over 3 years to determine long term outcomes from screening
False positive rates
False positive rates in those undergoing LDCT screening.
Measured: Over 3 years to determine long term outcomes from screening
False negative rates
False negative rates in those undergoing LDCT screening.
Measured: 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.
Measured: 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.
Measured: Over 3 years to determine long term outcomes from screening
Interval cancers
Interval cancers in those undergoing LDCT screening.
Measured: Over 3 years to determine long term outcomes from screening
Recall rates
Recall rates in those undergoing LDCT screening.
Measured: Over 3 years to determine long term outcomes from screening
Resection rates generated from screening
Resection rates generated from screening including incidental findings.
Measured: Over 3 years to determine long term outcomes from screening
Investigations generated from screening
Investigations generated from screening including incidental findings.
Measured: Over 3 years to determine long term outcomes from screening
Adverse events generated from screening
Adverse events generated from screening including incidental findings.
Measured: 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.
Measured: Over 3 years to determine long term outcomes from screening
Smoking prevalence
Smoking prevalence and amount at the start and end of screening.
Measured: Over 3 years to determine long term outcomes from screening
Undiagnosed airflow obstruction
Prevalence of undiagnosed airflow obstruction in the screened population.
Measured: Over 3 years to determine long term outcomes from screening
Coronary artery calcification
Prevalence of coronary artery calcification and QRISK2 score.
Measured: Over 3 years to determine long term outcomes from screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start20 Aug 2019
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Cancer Research UK, University of Manchester
- Responsible party
- Sponsor
- Investigators
- Philip Crosbie, Principal investigator, Manchester University NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409444
- Sponsor's protocol ID
- B00212
- Other IDs
- 252263 (IRAS), 19/LO/0404 (REC)
- Acronym
- qUEST
- Status last verified
- May 2023
- First submitted
- 21 May 2020
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only fully anonymised data will be sent to collaborating researchers
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04409444
- Acronym / sponsor ID
- qUEST / B00212
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,730 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Cancer Research UK, University of Manchester
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Data (main study) | – | Diagnostic Test: Lung Cancer ScreeningThis 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) | – | Diagnostic Test: Lung Cancer Screening, Diagnostic Test: BiomarkersThis 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Any individual attending the Manchester Lung Health service who has a lung health check as they meet the service inclusion exclusion criteria (see below):
- Age 55-80
- Ever smoker
- Registered with a GP in the North or East Manchester area
- Lung cancer diagnosis within 5 years
Key exclusion criteria (5 listed)
- Unable to give informed consent to study participation.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Cancer ScreeningThe lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model) | Diagnostic test | Biomarker (sub-study), Data (main study) |
| BiomarkersThis 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. | Diagnostic test | Biomarker (sub-study) |
Primary outcome
Uptake of the Manchester lung health check service
Time frame: 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.
Evaluation of biomarkers
Time frame: 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.
19 secondary outcomes
Screening adherence
Time frame: Over 3 years to determine long term outcomes from screening
Evaluation of screening numbers required to detect lung cancer
Time frame: Over 3 years to determine long term outcomes from screening
Comparison between cohort and those residents diagnosed in north and east manchester
Time frame: Over 3 years to determine long term outcomes from screening
Histological subtype for lung cancer related to screening service
Time frame: Over 3 years to determine long term outcomes from screening
Treatment for lung cancer related to screening service
Time frame: Over 3 years to determine long term outcomes from screening
Diagnosis route for lung cancer related to screening service
Time frame: Over 3 years to determine long term outcomes from screening
False positive rates
Time frame: Over 3 years to determine long term outcomes from screening
False negative rates
Time frame: Over 3 years to determine long term outcomes from screening
Rates of investigation of benign disease
Time frame: Over 3 years to determine long term outcomes from screening
Benign resection rate in participants
Time frame: Over 3 years to determine long term outcomes from screening
Interval cancers
Time frame: Over 3 years to determine long term outcomes from screening
Recall rates
Time frame: Over 3 years to determine long term outcomes from screening
Resection rates generated from screening
Time frame: Over 3 years to determine long term outcomes from screening
Investigations generated from screening
Time frame: Over 3 years to determine long term outcomes from screening
Adverse events generated from screening
Time frame: Over 3 years to determine long term outcomes from screening
Assessment of the British Thoracic Society pulmonary nodule guidelines
Time frame: Over 3 years to determine long term outcomes from screening
Smoking prevalence
Time frame: Over 3 years to determine long term outcomes from screening
Undiagnosed airflow obstruction
Time frame: Over 3 years to determine long term outcomes from screening
Coronary artery calcification
Time frame: Over 3 years to determine long term outcomes from screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Yes. Only fully anonymised data will be sent to collaborating researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Crosbie principal investigator
Manchester University NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Crosbie (01612912116, philip.crosbie@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of the Manchester lung health check service (time frame: Over 3 years to determine long term outcomes from screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.