Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT03975504
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2019-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Lung Cancer Screening (CLUS) Study Version 2.0
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D061848', 'term': 'Optical Imaging'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-27', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mortality rate of lung cancer', 'timeFrame': '5 years', 'description': 'Assess lung cancer mortality within next 5 years after first round of screening'}, {'measure': 'The attendance rate of high-risk individuals', 'timeFrame': '5 year', 'description': 'Evaluate the ability of AI in enhancing the attendance rate of high-risk individuals'}, {'measure': 'Diagnostic accuracy rate of lung cancer', 'timeFrame': '5 year', 'description': 'Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer'}], 'secondaryOutcomes': [{'measure': 'The mortality of all-cause', 'timeFrame': '5 years', 'description': 'Assess all-cause mortality within next 5 years after first round of screening'}, {'measure': 'The detection rate of lung nodules', 'timeFrame': '5 year', 'description': 'Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening'}, {'measure': 'The incidence rate lung cancer', 'timeFrame': '5 years', 'description': 'Assess the number of lung cancer incidences after each round of screening'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Neoplasms']}, 'referencesModule': {'references': [{'pmid': '36451312', 'type': 'DERIVED', 'citation': 'Zhang Y, Liu W, Zhang H, Sun B, Chen T, Hu M, Zhou H, Cao Y, Han B, Wu L. Extracellular vesicle long RNA markers of early-stage lung adenocarcinoma. Int J Cancer. 2023 Apr 1;152(7):1490-1500. doi: 10.1002/ijc.34386. Epub 2022 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'Our previous study, china lung cancer screening study version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). The present one arm study is performed to evaluate the efficacy of new techniques in improving the implementation of lung cancer screening and validate our previous findings. 6000 high-risk subjects (age 45-75) were recruited to take LDCT screening. (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible participants were those aged 45-75 years, and with either of the following risk factors:\n\n 1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;\n 2. malignant tumors history in immediate family members;\n 3. personal cancer history;\n 4. professional exposure to carcinogens;\n 5. long term exposure to second-hand smoke;\n 6. long term exposure to cooking oil fumes.\n\nExclusion Criteria:\n\n1. Had a CT scan of chest within last 12 months\n2. History of any cancer within 5 years'}, 'identificationModule': {'nctId': 'NCT03975504', 'briefTitle': 'China Lung Cancer Screening (CLUS) Study Version 2.0', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Community-based Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 2.0', 'orgStudyIdInfo': {'id': 'CHEST1809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'LDCT Screening', 'description': 'LDCT was performed at baseline + 2 biennial repeated LDCT rounds', 'interventionNames': ['Device: Low Dose Computed Tomography', 'Device: artificial intelligence (AI)', 'Diagnostic Test: autofluorescence imaging (AFI)']}], 'interventions': [{'name': 'Low Dose Computed Tomography', 'type': 'DEVICE', 'description': 'LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm', 'armGroupLabels': ['LDCT Screening']}, {'name': 'artificial intelligence (AI)', 'type': 'DEVICE', 'description': 'AI was performed in high-risk individuals recruitment and lung nodules management', 'armGroupLabels': ['LDCT Screening']}, {'name': 'autofluorescence imaging (AFI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'AFI applied in screening of centrally located SCC.', 'armGroupLabels': ['LDCT Screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Baohui Han', 'role': 'CONTACT', 'email': '18930858216@163.com', 'phone': '8618930858216', 'phoneExt': '8618930858216'}], 'facility': 'Shanghai Chest hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Baohui Han, MD Dr.', 'role': 'CONTACT', 'email': '18930858216@163.com', 'phone': '8618930858216'}, {'name': 'Yanwei Zhang, MD Dr.', 'role': 'CONTACT', 'email': 'zhangyw198691@163.com', 'phone': '8618930599895'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Baohui Han', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}