<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04409444</url>
  </required_header>
  <id_info>
    <org_study_id>B00212</org_study_id>
    <secondary_id>252263 (IRAS)</secondary_id>
    <secondary_id>19/LO/0404 (REC)</secondary_id>
    <nct_id>NCT04409444</nct_id>
  </id_info>
  <brief_title>Manchester Lung Health Study</brief_title>
  <acronym>qUEST</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cancer Research UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Manchester University NHS Foundation Trust</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Manchester Lung Health Study (qUEST) will assess the uptake of a community-based lung&#xD;
      cancer screening service and its impact across a deprived area of North and East Manchester,&#xD;
      which has high rates of lung cancer. One measure will be to compare the number and stage of&#xD;
      lung cancers detected through screening to those detected outside of screening. In addition&#xD;
      we will investigate the potential of a blood and nose test to detect lung cancer or to help&#xD;
      decide who would benefit from screening. We will also see if these samples can help with the&#xD;
      interpretation of CT scans. One of the problems with lung cancer CT screening is that you&#xD;
      detect lung nodules in which we are not sure if they are benign or cancerous. Therefore we&#xD;
      are also looking to see if a biomarker can help us work out which are cancerous and which are&#xD;
      benign.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 20, 2019</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Uptake of the Manchester lung health check service</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>The overall uptake will be assessed and analysed according to age, sex, smoking status, ethnicity and socio economic status.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of biomarkers</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Sensitivity and specificity of a biomarker or panel of biomarkers to detect early stage lung cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Screening adherence</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>overall and according to patient characteristics (age, sex, smoking status, ethnicity and socio economic status).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of screening numbers required to detect lung cancer</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Number needed to screen to detect one lung cancer according to lung cancer risk (as calculated by PLCOM2012).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison between cohort and those residents diagnosed in north and east manchester</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Lung cancer stage in the screened cohort compared to lung cancers diagnosed in residents of N+EM outside of the screening service.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histological subtype for lung cancer related to screening service</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Histological subtype of lung cancers in screening and outside of screening during the course of the service.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment for lung cancer related to screening service</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Treatment of lung cancers in screening and outside of screening during the course of the service.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnosis route for lung cancer related to screening service</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Route to diagnosis of lung cancers in screening and outside of screening during the course of the service.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>False positive rates</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>False positive rates in those undergoing LDCT screening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>False negative rates</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>False negative rates in those undergoing LDCT screening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of investigation of benign disease</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Rates of investigation of benign disease in those undergoing LDCT screening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benign resection rate in participants</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Benign resection rate in participants for those that have undergoing LDCT screening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interval cancers</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Interval cancers in those undergoing LDCT screening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recall rates</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Recall rates in those undergoing LDCT screening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resection rates generated from screening</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Resection rates generated from screening including incidental findings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigations generated from screening</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Investigations generated from screening including incidental findings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events generated from screening</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Adverse events generated from screening including incidental findings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the British Thoracic Society pulmonary nodule guidelines</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Assessment of performance of the BTS pulmonary nodules guideline in the setting of screening service.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking prevalence</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Smoking prevalence and amount at the start and end of screening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Undiagnosed airflow obstruction</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Prevalence of undiagnosed airflow obstruction in the screened population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coronary artery calcification</measure>
    <time_frame>Over 3 years to determine long term outcomes from screening</time_frame>
    <description>Prevalence of coronary artery calcification and QRISK2 score.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">9730</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Data (main study)</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biomarker (sub-study)</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung Cancer Screening</intervention_name>
    <description>The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)</description>
    <arm_group_label>Biomarker (sub-study)</arm_group_label>
    <arm_group_label>Data (main study)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Biomarkers</intervention_name>
    <description>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.</description>
    <arm_group_label>Biomarker (sub-study)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      A blood sample of up to 50mL will be taken from participants for analysis of circulating&#xD;
      tumour cells, circulating nucleic acid, proteins and genetic variations (single nucleotide&#xD;
      polymorphisms).&#xD;
&#xD;
      Nasal swab and brush samples will be taken for the identification of inflammatory markers.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals will be attending a lung health check as they are registered to a GP practice&#xD;
        in north and east Manchester, between the ages of 55-80 and an ever smoker.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Main data study:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        - Any individual attending the Manchester Lung Health service who has a lung health check&#xD;
        as they meet the service inclusion exclusion criteria (see below):&#xD;
&#xD;
        Manchester Lung Health service inclusion criteria:&#xD;
&#xD;
          -  Age 55-80&#xD;
&#xD;
          -  Ever smoker&#xD;
&#xD;
          -  Registered with a GP in the North or East Manchester area&#xD;
&#xD;
        Manchester Lung Health service exclusion Criteria:&#xD;
&#xD;
          -  Lung cancer diagnosis within 5 years&#xD;
&#xD;
          -  Listed on a palliative care register&#xD;
&#xD;
          -  Chest CT scan within 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Unable to give informed consent to study participation.&#xD;
&#xD;
        Biomarker sub-study:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Any individual attending the M-LHC service who is eligible and agrees to undergo LDCT&#xD;
             screening.&#xD;
&#xD;
          -  Has consented to the main study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to give informed consent to study participation&#xD;
&#xD;
          -  Decline participation in LDCT lung cancer screening&#xD;
&#xD;
          -  Known blood borne virus e.g. HIV or Hepatitis B, C&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Philip Crosbie</last_name>
    <role>Principal Investigator</role>
    <affiliation>Manchester University NHS Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Philip Crosbie</last_name>
    <phone>01612912116</phone>
    <email>philip.crosbie@manchester.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sara Waplington</last_name>
    <phone>01612912835</phone>
    <email>sara.waplington@mft.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Manchester University NHS Trust</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philip Crosbie</last_name>
      <phone>01612912116</phone>
      <email>philip.crosbie@manchester.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>Sara Waplington</last_name>
      <phone>01612912835</phone>
      <email>sara.waplington@mft.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Philip Crosbie</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Only fully anonymised data will be sent to collaborating researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04409444
org study id: B00212
secondary id: 252263 (IRAS)
secondary id: 19/LO/0404 (REC)
nct id: NCT04409444
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Uptake of the Manchester lung health check service
time frame: Over 3 years to determine long term outcomes from screening
description: The overall uptake will be assessed and analysed according to age, sex, smoking status, ethnicity and socio economic status.
measure: Evaluation of biomarkers
time frame: Over 3 years to determine long term outcomes from screening
description: Sensitivity and specificity of a biomarker or panel of biomarkers to detect early stage lung cancer.
measure: Screening adherence
time frame: Over 3 years to determine long term outcomes from screening
description: overall and according to patient characteristics (age, sex, smoking status, ethnicity and socio economic status).
measure: Evaluation of screening numbers required to detect lung cancer
time frame: Over 3 years to determine long term outcomes from screening
description: Number needed to screen to detect one lung cancer according to lung cancer risk (as calculated by PLCOM2012).
measure: Comparison between cohort and those residents diagnosed in north and east manchester
time frame: Over 3 years to determine long term outcomes from screening
description: Lung cancer stage in the screened cohort compared to lung cancers diagnosed in residents of N+EM outside of the screening service.
measure: Histological subtype for lung cancer related to screening service
time frame: Over 3 years to determine long term outcomes from screening
description: Histological subtype of lung cancers in screening and outside of screening during the course of the service.
measure: Treatment for lung cancer related to screening service
time frame: Over 3 years to determine long term outcomes from screening
description: Treatment of lung cancers in screening and outside of screening during the course of the service.
measure: Diagnosis route for lung cancer related to screening service
time frame: Over 3 years to determine long term outcomes from screening
description: Route to diagnosis of lung cancers in screening and outside of screening during the course of the service.
measure: False positive rates
time frame: Over 3 years to determine long term outcomes from screening
description: False positive rates in those undergoing LDCT screening.
measure: False negative rates
time frame: Over 3 years to determine long term outcomes from screening
description: False negative rates in those undergoing LDCT screening.
measure: Rates of investigation of benign disease
time frame: Over 3 years to determine long term outcomes from screening
description: Rates of investigation of benign disease in those undergoing LDCT screening.
measure: Benign resection rate in participants
time frame: Over 3 years to determine long term outcomes from screening
description: Benign resection rate in participants for those that have undergoing LDCT screening.
measure: Interval cancers
time frame: Over 3 years to determine long term outcomes from screening
description: Interval cancers in those undergoing LDCT screening.
measure: Recall rates
time frame: Over 3 years to determine long term outcomes from screening
description: Recall rates in those undergoing LDCT screening.
measure: Resection rates generated from screening
time frame: Over 3 years to determine long term outcomes from screening
description: Resection rates generated from screening including incidental findings.
measure: Investigations generated from screening
time frame: Over 3 years to determine long term outcomes from screening
description: Investigations generated from screening including incidental findings.
measure: Adverse events generated from screening
time frame: Over 3 years to determine long term outcomes from screening
description: Adverse events generated from screening including incidental findings.
measure: Assessment of the British Thoracic Society pulmonary nodule guidelines
time frame: Over 3 years to determine long term outcomes from screening
description: Assessment of performance of the BTS pulmonary nodules guideline in the setting of screening service.
measure: Smoking prevalence
time frame: Over 3 years to determine long term outcomes from screening
description: Smoking prevalence and amount at the start and end of screening.
measure: Undiagnosed airflow obstruction
time frame: Over 3 years to determine long term outcomes from screening
description: Prevalence of undiagnosed airflow obstruction in the screened population.
measure: Coronary artery calcification
time frame: Over 3 years to determine long term outcomes from screening
description: Prevalence of coronary artery calcification and QRISK2 score.
arm group label: Data (main study)
description: 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.
arm group label: Biomarker (sub-study)
description: 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.
intervention type: Diagnostic Test
intervention name: Lung Cancer Screening
description: The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)
arm group label: Biomarker (sub-study)
arm group label: Data (main study)
intervention type: Diagnostic Test
intervention name: Biomarkers
description: 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.
arm group label: Biomarker (sub-study)
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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
last name: Philip Crosbie
role: Principal Investigator
affiliation: Manchester University NHS Trust
last name: Philip Crosbie
phone: 01612912116
email: philip.crosbie@manchester.ac.uk
last name: Sara Waplington
phone: 01612912835
email: sara.waplington@mft.nhs.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: Yes
ipd description: Only fully anonymised data will be sent to collaborating researchers