{"registry": "ISRCTN", "registryId": "ISRCTN78513845", "source": "https://www.isrctn.com/ISRCTN78513845", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN78513845/format/default", "fetchedAt": "2026-10-07T17:01:37.823025Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "UK Lung cancer Screening pilot trial (UKLS)", "scientificTitle": "UK Lung cancer Screening pilot trial (UKLS)", "acronym": "UKLS", "hypothesis": "The overall aim is to determine whether there is a lung cancer mortality benefit from CT screening. The objective of a main UKLS trial would be to assess whether Low Dose Computed Tomography (LDCT) screening and treatment of early lesions will decrease lung cancer mortality compared to a control group without screening and will provide data required for an informed decision regarding the introduction of population CT screening for lung cancer. The objective of this pilot UKLS trial is to ensure the processes and components which will be used in the main trial are cohesive and practicable.\n\nMore details can be found at: http://www.nets.nihr.ac.uk/projects/hta/096101\nProtocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/54612/PRO-09-61-01.pdf", "primaryOutcome": "1. Will the proposed method of recruitment (based on the protocol of a two-stage postal survey of risk directly aimed at the general population) deliver the required numbers? This entails estimating: \n1.1. Response rates to questionnaires\n1.2. Proportion of subjects approached who are eligible\n1.3. Proportion of eligible subjects who consent to randomisation\n1.4. Proportion of subjects randomised to LDCT who comply with the intervention\n2. We shall also monitor the performance of all aspects of the clinical care pathway and the research evaluation technicalities, including for example the database system", "secondaryOutcome": "1. How many subjects need to be approached to obtain the required full trial population? \n2. Do the recruitment, randomisation and scanning protocols work in practice? Is the recruit‟s journey from initial survey to LDCT scanning logistically efficient? \n3. Are both fixed and mobile CT units practicable for trial purposes - is one preferable to the other in terms of cost/convenience? \n4. Testing of staff training programmes\n5. Testing of QA procedures, for radiology and technology, including radiation dose aspects\n6. Do questionnaires or consent/information procedures or documentation need revising? \n7. Review recruitment in hard-to-reach groups \n8. UKLS database capable of capturing all of the required information from the recruitment phase to CT screening, investigations and treatment\n11. Collection of blood/sputum specimens at the recruitment phase, and QC\n12. Provide screening data for HTA review at month 12 of the pilot for review and decision whether to fund the main UKLS trial\n13. Management of the UKLS through the Liverpool Cancer Trials Unit (LCTU)", "intervention": "\n\tEvery participant attends a recruitment centre where they watch a DVD, go through fully informed consent, undertake a lung function test, and provide a sample of blood, sputum and buccal scrape. They also complete a touch screen lifestyle and psychosocial questionnaire. Two weeks after the clinic appointment randomisation takes place. 50% are randomised into the CT scan arm and 50% are randomised into the non CT scan arm.\n\nCT scan arm\nOnce a participant is randomised to the CT scan arm they receive an appointment to undergo a CT scan of the chest.  Scans are initially read by the Consultant Radiologist at the appropriate hospital (Papworth and Liverpool Heart & Chest Hospitals). The scan images are then sent to the Royal Brompton Hospital in London to be read by a second Consultant Radiologist.  Once consensus is agreed the scan results are uploaded onto the UKLS database. Scan results are sent by post by the UKLS project management team within three weeks and can be:\n\nEnd of screening - no abnormality found\nRepeat scan in 12 months - nodule 3 mm to 4.9 mm\nRepeat scan in 3 months - nodule 5 mm to 9.9 mm\nReferral to multi-disciplinary team - nodule 10 mm or above\n\nA copy of the results letter is sent to the participants' GPs for information. Any clinically significant incidental findings are also advised to the GP so they can follow up as appropriate. Participants needing a 3- or 12-month repeat scan are contacted by the UKLS project management to book the appointment at the appropriate time.\n\nTwo weeks after receiving the scan results the participants receive a psychosocial questionnaire in the post to be completed and returned to the UKLS team.\n\nNon CT scan arm\nParticipants randomised to the non-CT scan arm will receive a psychosocial questionnaire two weeks post-randomisation.  \n\nFollow-up of both arms will continue for 10 years via the Health & Social Care Information Centre from whom we will receive data on deaths and cancers diagnosed. We will also seek Hospital Episode Statistics (HES) data on all recruited participants.\n\tOther\n\tNot Applicable\n\t\n      ", "condition": "\n\tLung cancer\n\tCancer\n\tMalignant neoplasm of bronchus and lung\n      ", "studyDesign": "Multi-centre randomised controlled trial", "overallEndDate": "2012-12-31T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2021-09-30T15:46:52.802Z", "eligibility": {"inclusion": "1. Risk criteria based on the LLP Risk Prediction Model (includes age, sex, smoking duration, history of previous pneumonia, history of previous cancer, family history [early/late onset], exposure to asbestos - algorithm)\n2. Males and females aged between 50 to 75 years old\n3. Fully informed written consent given", "exclusion": "1. Unable to give consent \n2. Co-morbidity which would unequivocally contraindicate either screening or treatment if lung cancer were detected \n3. A CT scan of the chest performed within one year of the invitation to be screened\n4. Any condition precluding written informed consent\n5. Inability to lie flat\n6. Weight greater than 200 kg (too large for CT scanner)", "ageRange": "Other", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2011-04-01T00:00:00.000Z", "recruitmentEnd": "2012-12-31T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "4000", "totalFinalEnrolment": "4055"}, "countries": ["United Kingdom", "England"], "locations": [{"name": "University of Liverpool Cancer Research Centre", "city": "Liverpool", "state": "", "country": "United Kingdom", "zip": "L3 9TA"}], "sponsors": [{"organisation": "Royal Liverpool & Broadgreen University Hospital Trust (UK)", "sponsorType": "Hospital/treatment centre", "rorId": "https://ror.org/009sa0g06"}], "funders": [{"name": "Health Technology Assessment Programme", "fundRef": "http://dx.doi.org/10.13039/501100000664"}]}, "studySha256": "2c748df0af56cba92a0e021ed59d3410a8cf5a3b8ee1a1cf3f774a2365adedc9"}