Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Manchester Lung Health Study (qUEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04409444
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : June 1, 2020
Sponsor:
Collaborators:
Cancer Research UK
University of Manchester
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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.

Condition or disease Intervention/treatment
Lung Cancer Diagnostic Test: Lung Cancer Screening Diagnostic Test: Biomarkers

Layout table for study information
Study Type : Observational
Estimated Enrollment : 9730 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Screening adherence [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    overall and according to patient characteristics (age, sex, smoking status, ethnicity and socio economic status).

  2. Evaluation of screening numbers required to detect lung cancer [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Number needed to screen to detect one lung cancer according to lung cancer risk (as calculated by PLCOM2012).

  3. Comparison between cohort and those residents diagnosed in north and east manchester [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Lung cancer stage in the screened cohort compared to lung cancers diagnosed in residents of N+EM outside of the screening service.

  4. Histological subtype for lung cancer related to screening service [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Histological subtype of lung cancers in screening and outside of screening during the course of the service.

  5. Treatment for lung cancer related to screening service [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Treatment of lung cancers in screening and outside of screening during the course of the service.

  6. Diagnosis route for lung cancer related to screening service [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Route to diagnosis of lung cancers in screening and outside of screening during the course of the service.

  7. False positive rates [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    False positive rates in those undergoing LDCT screening.

  8. False negative rates [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    False negative rates in those undergoing LDCT screening.

  9. Rates of investigation of benign disease [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Rates of investigation of benign disease in those undergoing LDCT screening.

  10. Benign resection rate in participants [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Benign resection rate in participants for those that have undergoing LDCT screening.

  11. Interval cancers [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Interval cancers in those undergoing LDCT screening.

  12. Recall rates [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Recall rates in those undergoing LDCT screening.

  13. Resection rates generated from screening [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Resection rates generated from screening including incidental findings.

  14. Investigations generated from screening [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Investigations generated from screening including incidental findings.

  15. Adverse events generated from screening [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Adverse events generated from screening including incidental findings.

  16. Assessment of the British Thoracic Society pulmonary nodule guidelines [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Assessment of performance of the BTS pulmonary nodules guideline in the setting of screening service.

  17. Smoking prevalence [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Smoking prevalence and amount at the start and end of screening.

  18. Undiagnosed airflow obstruction [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Prevalence of undiagnosed airflow obstruction in the screened population.

  19. Coronary artery calcification [ Time Frame: Over 3 years to determine long term outcomes from screening ]
    Prevalence of coronary artery calcification and QRISK2 score.


Biospecimen Retention:   Samples With DNA

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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409444


Contacts
Layout table for location contacts
Contact: Philip Crosbie 01612912116 philip.crosbie@manchester.ac.uk
Contact: Sara Waplington 01612912835 sara.waplington@mft.nhs.uk

Locations
Layout table for location information
United Kingdom
Manchester University NHS Trust Recruiting
Manchester, United Kingdom
Contact: Philip Crosbie    01612912116    philip.crosbie@manchester.ac.uk   
Contact: Sara Waplington    01612912835    sara.waplington@mft.nhs.uk   
Principal Investigator: Philip Crosbie         
Sponsors and Collaborators
Manchester University NHS Foundation Trust
Cancer Research UK
University of Manchester
Investigators
Layout table for investigator information
Principal Investigator: Philip Crosbie Manchester University NHS Trust
Layout table for additonal information
Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04409444    
Other Study ID Numbers: B00212
252263 (IRAS) ( Other Identifier: Health Research Authority )
19/LO/0404 (REC) ( Other Identifier: Health Research Authority )
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only fully anonymised data will be sent to collaborating researchers

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases