Lung cancer Cancer
Conditions
Interventions
Screening (Work Package 1):
Adults over 40 who have been referred for a chest X-ray by their GP will be reviewed by the radiology clinical team. They will phone potential patients to discuss the study
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: Added 23/01/2026: Please note, patients cannot be referred directly into the study by their GP, or volunteer themselves. The only way to participate is if a patient is invited by a member of the MEDLEY team from one of the participating centres. Patients meeting ALL the following criteria will be considered for enrolment into the study for Work Package 1: 1. Age 40 years or more at the time the consent form is signed 2. Have had a CXR requested in general practice which fulfils NICE NG12 criteria 3. Consent to participate in WP1 (written/verbal/eConsent) Eligibility for Work Package 3 is split for patients, GPs and stakeholders: For patients: 1. Met the first two inclusion criteria listed above for WP1 2. Consent to participate in WP3 (written/verbal/e-consent informed consent) Note: patients who decline to participate in WP1 will still be given the opportunity to take part in WP3 3. Do not meet exclusion criteria 1, 2, 4, or 5 of WP1 exclusion criteria For GPs: 1. Consent to participate in WP3 (written/verbal/e-consent informed consent) 2. Current practicing General Practitioner 3. Either 3.1. Has referred a patient for a chest X-ray who was subsequently consented to WP1 OR 3.2. Has referred a patient meeting NG12 criteria for CXR For stakeholders: 1. Consent to participate in WP3 (written/verbal/e-consent informed consent). 2. Relevant professional background, including: 2.1. Clinician in respiratory medicine, radiology and radiography 2.2. Senior leaders invited from professional organisations (e.g. Royal College of Radiologists, UK Lung Cancer Coalition) 2.3. Commissioners (e.g. Integrated Care Boards) 2.4. Policy makers (e.g. NHS England) 2.5. Patient advocacy groups
Exclusion criteria
Exclusion criteria: Patients will be excluded from Work Package 1 of this study for ANY of the following reasons: 1. Present with haemoptysis and/or have a pending urgent suspected cancer referral 2. Have had thoracic CT or LDCT within the last year 3. Unable to, or chooses not to, receive a LDCT 4. Currently undergoing anti-cancer treatment 5. Is pregnant* or currently breastfeeding 6. Previously registered in the MEDLEY study *Assessment of pregnancy potential (or exemption) completed as per national guidelines and/or local Trust policy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to establish the feasibility of a future definitive trial. As such the below aims will inform the decision to proceed to, and/or inform the design of a definitive trial: WP1 quantitative outcomes relating to feasibility and deliverability of a definitive trial: 1. Recruitment rate is measured by the number of participants recruited per centre per month 2. Proportions of eligible patients who consent/do not consent to participate is measured using the numbers recorded on the non-registration log throughout the recruitment period 3. Time from site approach to opening, from opening to recruiting first participant, and duration of site recruitment. Measured using the dates recorded in spreadsheet site setup/recruitment logs Estimates of diagnostic accuracy listed below are all measured using medical record review at months 4 and 12: 1. To inform sample size calculation for a definitive trial: 1.1. Sensitivity and specificity of CXR using contemporaneous LDCT as a reference standard 1.2. Correlation/discordance between LDCT and CXR test results: proportions of paired tests that agree/disagree on the presence of lung cancer Imaging logistics listed below are measured using the data recorded in spreadsheet logs and in imaging eCRFs 1. Proportions of recruited participants not undergoing imaging with LDCT and CXR Clinical outcomes listed below are all measured using medical record review at months 4 and 12 1. Prevalence of lung cancer among recruited patients WP2 economic outcomes measured using information from participant questionnaires and medical record review at month 4 and month 12: 1. Value of information assessment for a definitive trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| The outcome measures that will be evaluated within this feasibility study are as follows: Estimates of diagnostic accuracy listed below are all measured using medical record review at months 4 and 12: 1. To inform sample size calculation for a definitive trial: 1.1. Comparative sensitivity and specificity of LDCT and CXR using lung cancer diagnoses within one year (given the shorter follow-up this being a feasibility study) as reference standard 1.2. Sensitivity of CXR reported by cancer stage using contemporaneous LDCT as a reference standard Imaging logistics listed below are measured using the data recorded in spreadsheet logs and in imaging eCRFs: 1. Time from CXR request to imaging & report, and reporting time by radiologist 2. Incidences of unblinding (CXR) 3. Total number of CT examinations (chest and other) undertaken per week 4. Total number of CXR examinations (GP requested and total) undertaken per week 5. Number of full-time equivalent radiographers and radiologists on rota per week 6. Proportion of CXR requests received that fulfil NG12 criteria on 1 day per week (week 1 = Monday, week 2 = Tuesday etc) Clinical outcomes listed below are all measured using medical record review at months 4 and 12: 1. Stage and histology of lung cancer at diagnosis 2. Prevalence of indeterminate pulmonary nodules requiring CT surveillance 3. Prevalence of incidental findings 4. Subsequent investigations because of imaging (lung cancer and incidental findings) 5. Eventual treatments for diagnoses resulting from imaging (lung cancer and incidental findings) 6. Harms of investigation or treatment (including but not limited to invasive investigations or surgery for benign disease) 7. Prospective validation (discrimination and calibration) of risk stratification to select patients for LDCT WP2 economic outcomes measured using information from participant questionnaires and medical record review at months 4 and 12: 1. Cost-effectiveness analysis of LDCT versus CXR using an | — |
Countries
England, United Kingdom
Outcome results
None listed