{"registry": "ISRCTN", "registryId": "ISRCTN80745975", "source": "https://www.isrctn.com/ISRCTN80745975", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN80745975/format/default", "fetchedAt": "2026-10-07T17:01:16.888546Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "A randomised controlled trial of surveillance for the early detection of lung cancer in an at risk group", "scientificTitle": "A randomised controlled trial of surveillance for the early detection of lung cancer in an at risk group", "acronym": "Lung-SEARCH", "hypothesis": "The trial will test the hypothesis that annual surveillance of chronic obstructive pulmonary disease (COPD) patients who are long-term smokers with abnormal sputum cytology and/or cytometry using fluorescence bronchoscopy and low dose spiral computed tomography (CT) detects a large proportion of lung cancer incidence at early stages when curative treatment is feasible. \n\nPlease note that as of 03/10/2008 this record has been updated. Any changes to the trial information can be found in the relevant field under the above update date. \n\nOn 17/02/2011 the target number of participants was changed from 1300 to 1700.", "primaryOutcome": "The primary endpoint is the proportion of lung cancers that are diagnosed at stage I or II.", "secondaryOutcome": "1. Uptake of screening (the proportion of patients in the surveillance arm who attend each year, among those invited to attend). This can be further divided into those who decline auto-FB, CT scan or yearly sputum.\n2. The proportion of patients in the surveillance arm who have abnormal sputum cytology\n3. The proportion of patients in the surveillance arm who have abnormal sputum cytometry\n4. Death from lung cancer\n5. Proportion of failed sputum samples, i.e. where it is not possible to obtain adequate sputum samples\n6. Prevalence of pre-invasive disease in patients with abnormal cytometry in the\nactive arm\n7. Numbers of patients with pre-invasive lesions developing lung cancer locally and at remote sites within the lung in the active arm", "intervention": "\n\tAmended as of 03/10/2008:\nPoint one in the surveillance arm (a baseline blood sample will be taken) has now been removed from the interventions section. All other information remains the same. \n\nInitial information at time of registration:\nIn the surveillance arm:\n1. A baseline blood sample will be taken\n2. A sputum sample will be collected for cytology and cytometry:\n2.1. Normal sputum = sputum without metaplastic cells, only containing alveolar macrophages. If the sputum sample is normal the subject will be asked to provide sputum annually.\n2.2. Abnormal sputum = low-grade (LSIL) and high-grade lesion (HSIL) squamous intraepithelial lesions. If the sputum sample is abnormal the subject will have an annual CT scan followed by a fluorescence bronchoscopy. The frequency of bronchoscopy is dependent upon the histology results.\n\nIn the control arm:\nPatients recruited into the control arm will be managed according to the usual practice of their hospital or general practice for their COPD treatment. They will have no particular investigations except those that may arise due to a change in their clinical condition. However, those patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years.\n\tOther\n\tPhase III\n\t\n      ", "condition": "\n\tLung cancer\n\tCancer\n\tMalignant neoplasm of the lung\n      ", "studyDesign": "Randomised controlled trial", "overallEndDate": "2014-05-01T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT00512746", "lastUpdated": "2020-09-23T15:10:26.826Z", "eligibility": {"inclusion": "Amended as of 03/10/2008: \nPoint two of the inclusion criteria has been amended as follows:\n2. Ex-smokers who have quit within 8 years with a greater than or equal to 20 pack-years smoking history and/or 20-year duration of smoking \n\nInitial information at time of registration:\n1. Current smokers: greater than or equal to 20 pack-years smoking history and/or 20-year duration of smoking \n2. Ex-smokers who have quit within 5 years with a greater than or equal to 20 pack-years smoking history and/or 20-year duration of smoking \n3. No upper age limit but life expectancy must be at least 5 years\n4. No history of malignant disease during the previous 5 years except non-melanomatous skin cancers\n5. No other serious co-morbidity\n6. Written informed consent \n7. Mild to moderate COPD as defined by the Global Initiative on Obstructive Lung Disease (GOLD) criteria\n8. Mild: \n8.1. Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than 70\n8.2. FEV1 greater than or equal to 80% predicted\n9. Moderate: \n9.1. FEV1/FVC less than 70%\n9.2. FEV1 50-80% predicted\n(Spirometric values will be taken post bronchodilator according to the recommendations in the GOLD criteria)", "exclusion": "1. Inadequate lung function (FEV1 less than 50% predicted after bronchodilator) \n2. History of malignant disease during the previous 5 years except non melanomatous skin cancers \n3. Evidence of severe or uncontrolled systemic diseases that, in the view of the investigator, makes it undesirable for the patient to participate in the trial\n4. Any disorder making reliable informed consent impossible\n5. Patient unlikely to co-operate with a 5 year follow up", "ageRange": "Adult", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2007-08-24T00:00:00.000Z", "recruitmentEnd": "2011-04-01T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "1700", "totalFinalEnrolment": "1568"}, "countries": ["United Kingdom", "England"], "locations": [{"name": "University College London Hospitals NHS Trust", "city": "London", "state": "", "country": "United Kingdom", "zip": "WC1E 5DB"}], "sponsors": [{"organisation": "University College London (UK)", "sponsorType": "University/education", "rorId": "https://ror.org/02jx3x895"}], "funders": [{"name": "Cancer Research UK (CRUK) (UK) (ref: C5784/A7743)", "fundRef": "http://dx.doi.org/10.13039/501100000289"}]}, "studySha256": "afa8efaab739f591a89ade969573dde458d2df380d4fd1159c53be48df3abf17"}