{"registry": "ISRCTN", "registryId": "ISRCTN42704678", "source": "https://www.isrctn.com/ISRCTN42704678", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN42704678/format/default", "fetchedAt": "2026-10-07T17:01:39.699308Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "The Yorkshire Lung Screening Trial", "scientificTitle": "A randomised controlled trial to evaluate invitation to community-based low dose computed tomography (LDCT) screening for lung cancer versus usual care in a targeted population at risk", "acronym": "YLST", "hypothesis": "Current study hypothesis as of 20/02/2024: \n\nScreening for Lung Cancer with Low Dose Computed Tomography (LDCT) scans reduced deaths in a large US trial and is now routine care in North America. The UK National Screening Committee recently approved a screening programme for lung cancer in the UK. Lung cancer is much more common in deprived communities, and yet these populations are less likely to participate in both established screening programmes and research studies. Unanswered questions about lung cancer screening include: how to design services that are convenient and accessible to people from deprived populations who are most at risk; how much extra benefit might be seen with targeted screening of high-risk current or ex-smokers in the UK compared to the US; is overdiagnosis a problem (where screening detects indolent cancers that would not have caused patients harm during their lifetime); and what effect screening has on smoking rates.\nIn 2021 the study was extended for a third screening round. Existing participants will receive an invitation to a third round of biennial screening.\n\nParticipants who were previously ineligible due to falling below the risk stratification criteria for receiving a scan will have their risk score recalculated and be invited for screening if now likely to be eligible based on updated age and smoking history parameters.\n\nNon-responders to previous screening invitation material will be randomised to a pathway navigator approach. Those allocated to the intervention arm will receive a letter informing them of a telephone appointment to discuss lung screening. At this telephone appointment staff trained in pathway navigator techniques will address any barriers to capability, opportunity and motivation for attending screening using problem-solving, behaviour change techniques and practical arrangements.\n\n_____\n\nPrevious study hypothesis:\n\nScreening for Lung Cancer with Low Dose Computed Tomography (LDCT) scans reduced deaths in a large US trial and is now routine care in North America. The UK National Screening Committee has yet to approve a screening programme for lung cancer. Lung cancer is much more common in deprived communities, and yet these populations are less likely to participate in both established screening programmes and research studies. Unanswered questions about lung cancer screening include: how to design services that are convenient and accessible to people from deprived populations who are most at risk; how much extra benefit might be seen with targeted screening of high-risk current or ex-smokers in the UK compared to the US; is overdiagnosis a problem (where screening detects indolent cancers that would not have caused patients harm during their lifetime); and what effect screening has on smoking rates. \n\nThe Yorkshire Lung Screening Trial aims to test targeted LDCT screening in community settings concentrating on deprived areas of Leeds.", "primaryOutcome": "Current primary outcome measure as of 20/02/2024: \n\nYLST Primary Outcome Measures\n1. The proportion of the study population allocated to intervention who undergo telephone assessment and are screened according to the USPSTF, PLCO and LLP criteria\n2. Lung cancers identified in participants selected for LDCT screening according to the USPSTF, PLCO and LLP criteria over two rounds of biennial screening\n3. The incidence of advanced lung cancer in the intervention and control arms over the course of the study\n\nPathway Navigator Primary Outcomes\n1. The number undergoing initial telephone assessment of lung cancer risk.\n2. The number undergoing a LDCT screening scan.\n\n_____\n\nPrevious primary outcome measures as of 02/04/2020:\n\n1. The proportion of the study population allocated to intervention who undergo telephone assessment and are screened according to the USPSTF, PLCO and LLP criteria\n2. Lung cancers identified in participants selected for LDCT screening according to the USPSTF, PLCO and LLP criteria over two rounds of biennial screening\n3. The incidence of advanced lung cancer in the intervention and control arms over the course of the study\n\n_____\n\nPrevious primary outcome measures:\n\n1. The proportion of the study population allocated to intervention who undergo telephone assessment and are screened according to the USPSTF, PLCO and LLP criteria, measured at initial telephone triage at study baseline\n2. Lung cancers identified in patients selected for LDCT screening according to the USPSTF, PLCO and LLP criteria over two rounds of biennial screening, measured at study end (5-6 years following initial recruitment)\n3. The incidence of advanced lung cancer in the intervention and control arms over the course of the study, measured using local medical records and national database (National Cancer Registration and Analysis Service) at study end (5-6 years following initial recruitment)", "secondaryOutcome": "Current secondary outcome measures as of 20/02/2024: \n\nYLST Secondary Outcome Measures\n1. Incremental cost-effectiveness ratio for community-based lung cancer screening overall and according to the three criteria for identifying candidates for screening\n2. Screening performance including the following parameters:\n2.1. Cancer detection rate and number needed to screen to detect one lung cancer according to risk criteria over two screening rounds\n2.2. False-positive and false-negative rate\n2.3. Rate of investigation of benign disease and benign surgical resection rate\n2.4. Attendance by LDCT screening round and according to participant characteristics (age, sex, smoking status, ethnicity and SES)\n2.5. Treatment of screen-detected lung cancer including surgical resection rate\n2.6. Investigations, treatments and adverse events generated from screening including incidental findings\n2.7. Interval cancers and recall rates in those undergoing screening\n3. Smoking prevalence at the start and end of the study in the intervention arm and usual care arm\n4. Participation rates in telephone assessment by age, sex, smoking status, ethnicity and SES\n5. Route to diagnosis, histological subtype, stage and treatment of lung cancers in the intervention (LDCT screened group, eligible respondents, non-respondents and ineligible low risk responders) and usual care arms\n6. Lung cancer and all-cause mortality by trial arm\n7. Numbers of nodules detected, proportion with eventual diagnosis of cancer by: size (volume), Pancan malignancy risk prediction score and volumetry-derived Volume Doubling Time (VDT)\n8. Prevalence of undiagnosed airflow obstruction and coronary artery calcification in the screened population\n9. Quality of life measured using EQ-5D and SF-12 scores\n\nPathway Navigator Secondary Outcomes\nSecondary outcomes include: demographic, clinical and risk parameters of people undergoing telephone risk-assessment; number of people eligible for screening following telephone risk-assessment; number of screen-detected cancers diagnosed; costs; a mixed-methods process evaluation.\n\n_____\n\nPrevious secondary outcome measures as of 02/04/2020:\n\n1. Incremental cost-effectiveness ratio for community-based lung cancer screening overall and according to the three criteria for identifying candidates for screening\n2. Screening performance including the following parameters:\n2.1. Cancer detection rate and number needed to screen to detect one lung cancer according to risk criteria over two screening rounds\n2.2. False-positive and false-negative rate\n2.3. Rate of investigation of benign disease and benign surgical resection rate\n2.4. Attendance by LDCT screening round and according to participant characteristics (age, sex, smoking status, ethnicity and SES)\n2.5. Treatment of screen-detected lung cancer including surgical resection rate\n2.6. Investigations, treatments and adverse events generated from screening including incidental findings\n2.7. Interval cancers and recall rates in those undergoing screening\n3. Smoking prevalence at the start and end of the study in the intervention arm and usual care arm\n4. Participation rates in telephone assessment by age, sex, smoking status, ethnicity and SES\n5. Route to diagnosis, histological subtype, stage and treatment of lung cancers in the intervention (LDCT screened group, eligible respondents, non-respondents and ineligible low risk responders) and usual care arms\n6. Lung cancer and all-cause mortality by trial arm\n7. Numbers of nodules detected, proportion with eventual diagnosis of cancer by: size (volume), Pancan malignancy risk prediction score and volumetry-derived Volume Doubling Time (VDT)\n8. Prevalence of undiagnosed airflow obstruction and coronary artery calcification in the screened population\n9. Quality of life measured using EQ-5D and SF-12 scores\n\n_____\n\nPrevious secondary outcome measures:\n\n1. Participation rates in telephone assessment by age, sex, smoking status, ethnicity and SES, measured using information collected from primary care databases at initial telephone triage at study baseline\n2. Attendance by LDCT screening rounds, measured at baseline screen (T0) and T2 screen\n3. Numbers attending LDCT screening and by patient characteristics (age, sex, smoking status, ethnicity and SES) by screening round, measured at baseline screen (T0) and T2 screen\n4. Adverse events in attenders of the LHC/LDCT scanning on the mobile van, recorded on electronic case report form at baseline screen (T0) and T2 screen\n5. Number needed to screen to detect one lung cancer for each of the three risk criteria over the two rounds of screening, measured at study end (5-6 years following initial recruitment)\n6. Cancer detection rate for each of the three risk criteria over two rounds of LDCT screening, measured at study end (5-6 years following initial recruitment)\n7. Lung cancer stage in the intervention arm (LDCT screened group, eligible respondents, non-respondents and ineligible low risk responders) and usual care arms over the course of the study, measured using local medical records and national database (National Cancer Registration and Analysis Service) at study end (5-6 years following initial recruitment)\n8. Route to diagnosis, histological subtype and treatment of lung cancers intervention arm (LDCT screened group, eligible respondents, non-respondents and ineligible low risk responders) and usual care arms over the course of the study, measured using local medical records at study end (5-6 years following initial recruitment)\n9. Lung cancer and all-cause mortality by trial arm, measured using UK Office for National Statistics at study end (5-6 years following initial recruitment)\n10. Sensitivity, specificity, PPV and NPV for each of the three risk criteria after at least 6 years of follow up (funding dependent), measured at study end (5-6 years following initial recruitment)\n11. False positive rates, false negative rates, rates of investigation of benign disease, benign resection rate in participants, interval cancers, recall rates in those undergoing LDCT screening, measured at study end (5-6 years following initial recruitment)\n12. Resection rates, investigations, treatments and adverse events generated from screening including incidental findings, measured using local medical records at study end (5-6 years following initial recruitment)\n13. Numbers of nodules detected, proportion with eventual diagnosis of cancer by volume, Pancan malignancy risk prediction score and volumetry-derived Volume Doubling Time, measured using local medical records at study end (5-6 years following initial recruitment)\n14. Incremental cost-effectiveness ratio for community-based lung cancer screening overall and according to the three criteria for identifying candidates for screening, measured using local medical records at study end (5-6 years following initial recruitment)\n15. Smoking prevalence at start and end of study in intervention arm and usual care arm, smoking and smoking cessation rates in those invited to LDCT screening, measured using primary care databases at time of initial data extraction and at study end\n16. Prevalence of undiagnosed airflow obstruction in the screened population, measured using spirometry data recorded as part of Lung Health Check at baseline screen (T0)\n17. Prevalence of coronary artery calcification, recorded on radiology report from scan at baseline screen (T0)\n18. Quality of life (SF-12, EQ-5D) and anxiety/worry measures (Cancer Worry Scale adapted to lung cancer), measured at baseline screen (T0) and T2 screen", "intervention": "\n\tCurrent interventions as of 20/02/2024: \n\nThe trialists wish to use a Zelen’s design, where they randomise 55-80 year old smokers or ex-smokers to intervention or usual care groups before they approach them. The intervention group will be invited to assessment for a Lung Health Check (including LDCT screening for high-risk people) framed as a pilot health service. Other studies using this approach have shown greater participation from deprived populations. The trialists will compare outcomes between the invited group and a usual care group, who won’t be invited to take part or know that they are in a research study. By comparing outcomes with a control population, they will be able to assess the true benefits (of reducing number of late stage cancers, and therefore lives saved) and possible harms (of overdiagnosis) of introducing screening in the UK.\n\nYLST plans 2 rounds of invitation to LDCT screening at an interval of 2 years. For participants being screened, there will be 4 years to 6 years of follow up from date of baseline LDCT screen. For all randomised participants, the trialists plan up to 6 years follow up from point of randomisation to ascertain and compare lung cancer outcomes including diagnoses and rates of advanced cancers based on staging. Longer term follow up on lung cancer outcomes including incidence of lung cancer, incidence of advanced cancer and mortality may be undertaken subject to funding and permissions from the Confidentiality Advisory Group and Research Ethics Committee.\n\nAt screening round three, non-responders to previous screening invitation material will be randomised to a pathway navigator approach. Those allocated to the intervention arm will receive a letter informing them of a telephone appointment to discuss lung screening. At this telephone appointment staff trained in pathway navigator techniques will address any barriers to capability, opportunity and motivation for attending screening using problem-solving, behaviour change techniques and practical arrangements.\n\n_____\n\nPrevious interventions:\n\n\nThe trialists wish to use a Zelen’s design, where they randomise 55-80 year old smokers or ex-smokers to intervention or usual care groups before they approach them. The intervention group will be invited to assessment for a Lung Health Check (including LDCT screening for high-risk people) framed as a pilot health service. Other studies using this approach have shown greater participation from deprived populations. The trialists will compare outcomes between the invited group and a usual care group, who won’t be invited to take part or know that they are in a research study. By comparing outcomes with a control population, they will be able to assess the true benefits (of reducing number of late stage cancers, and therefore lives saved) and possible harms (of overdiagnosis) of introducing screening in the UK.\n\nYLST plans 2 rounds of invitation to LDCT screening at an interval of 2 years. For participants being screened, there will be 4 years to 6 years of follow up from date of baseline LDCT screen. For all randomised participants, the trialists plan up to 6 years follow up from point of randomisation to ascertain and compare lung cancer outcomes including diagnoses and rates of advanced cancers based on staging. Longer term follow up on lung cancer outcomes including incidence of lung cancer, incidence of advanced cancer and mortality may be undertaken subject to funding and permissions from the Confidentiality Advisory Group and Research Ethics Committee.\n\tOther\n\t\n\t\n      ", "condition": "\n\tLung cancer\n\tCancer\n\tCancer/ Malignant neoplasms of respiratory and intrathoracic organs\n      ", "studyDesign": "Randomized; Interventional; Design type: Screening, Imaging, Complex Intervention", "overallEndDate": "2025-11-30T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2026-07-01T13:01:08.675269784Z", "eligibility": {"inclusion": "The inclusion criteria for entry into the randomisation cohort are:\n1. Registered with a participating General Practice within the Leeds CCG area\n2. Registered as current or ex-smoker in primary care databases\n3. Age between 55 and 80 years (inclusive) at the time of randomisation\n\nThe inclusion criteria for being invited to attend a mobile lung health check following contacting the telephone triage service are any of:\n1. 30 pack year history of smoking and current smoker, and quit within the last 15 years, (USPSTF criteria)\n2. Lung cancer risk of ≥1.51% over 6 years as calculated by the PLCOM2012 score\n3. Lung cancer risk of ≥5% over 5 years as calculated by the LLPv2. score", "exclusion": "1. Unable to provide written informed consent\n2. Diagnosed with lung cancer within past 5 years\n3. Diagnosed with incurable cancer\n4. CT thorax within past 12 months\n5. Registered on any of the following primary care databases:\n5.1. Palliative care register\n5.2. Dementia register\n5.3. Frailty index > (to be decided)\n6. Recorded type 2 objection to participation in the General Practice Extraction Service", "ageRange": "Adult", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2018-09-01T00:00:00.000Z", "recruitmentEnd": "2024-10-31T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "6892", "totalFinalEnrolment": "8847"}, "countries": ["United Kingdom", "England"], "locations": [{"name": "Leeds Teaching Hospitals NHS Trust", "city": "Leeds", "state": "", "country": "England", "zip": "LS9 7TF"}], "sponsors": [{"organisation": "University of Leeds", "sponsorType": "University/education", "rorId": "https://ror.org/024mrxd33"}], "funders": [{"name": "Yorkshire Cancer Research; Grant Codes: L403", "fundRef": "http://dx.doi.org/10.13039/100011703"}]}, "studySha256": "0afd9d7c7cf76152e362f97ea329e39eb4db54ee7499ab5c3c2af805acfa3571"}