Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 11:39 PM
Study NCT ID:
NCT04938804
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2021-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-risk Based Lang Cancer Screening With a One-off LDCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-31', 'releaseDate': '2024-08-09'}], 'estimatedResultsFirstSubmitDate': '2024-08-09'}}, '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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-07', 'studyFirstSubmitDate': '2021-06-12', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The detection rate of lung cancer', 'timeFrame': '11 years', 'description': 'Lung cancer detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases.'}, {'measure': 'To investigate the various factors associated with the development of lung cancer', 'timeFrame': '11 years', 'description': 'To investigate the various factors associated with the development of lung cancer'}], 'secondaryOutcomes': [{'measure': 'Detection rates of lung cancer and the proportion of stage I lung cancer cases between "high-risk" and "non-high-risk" groups', 'timeFrame': '11 years', 'description': 'The detection rate of lung cancer among people with "high-risk" and "non-high-risk"factors'}, {'measure': 'Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments)', 'timeFrame': '11 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Screening'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '39689940', 'type': 'DERIVED', 'citation': 'Ye W, Fu W, Li C, Li J, Xiong S, Cheng B, Xu B, Wang Q, Feng Y, Chen P, He J, Liang W. Diameter thresholds for pure ground-glass pulmonary nodules at low-dose CT screening: Chinese experience. Thorax. 2025 Jan 17;80(2):76-85. doi: 10.1136/thorax-2024-221642.'}]}, 'descriptionModule': {'briefSummary': 'Guangzhou Lung-Care Project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of LC, recruiting residents aged 40-74 years from four communities in Guangzhou between 2015 and 2021.The primary outcome was LC detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases, and to investigate the various factors associated with the development of LC.', 'detailedDescription': 'Guangzhou Lung-Care Project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of LC, recruiting residents aged 40-74 years from four communities in Guangzhou between 2015 and 2021. Follow-up for post-screening management and survival was recorded. The primary outcome was LC detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases, and to investigate the various factors associated with the development of LC. Additionally, we compared the detection rates of LC and the proportion of stage I LC cases between "high-risk" and "non-high-risk" groups according to the National Comprehensive Cancer Network (NCCN) guidelines and Chinese guideline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum age of 40 years among the residents in Guangzhou\n\nExclusion Criteria:\n\n* Persons who had a diagnosis or treatment related to LC within the past 5 years, had undergone chest CT within the past year, or had significant cancer-related symptoms (e.g., hemoptysis, dyspnea, inability to climb two flights of stairs).'}, 'identificationModule': {'nctId': 'NCT04938804', 'briefTitle': 'Non-risk Based Lang Cancer Screening With a One-off LDCT', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Non-risk Based Lung Cancer Screening With One-time Low-dose Computed Tomography: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'GZLUNG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening group', 'interventionNames': ['Device: Low-dose computed tomography']}], 'interventions': [{'name': 'Low-dose computed tomography', 'type': 'DEVICE', 'description': 'The Low-dose computed tomography is conducted according to the guideline suggested by American College of Radiology.', 'armGroupLabels': ['Screening group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenhua Liang, MD', 'role': 'CONTACT', 'email': 'liangwh1987@163.com', 'phone': '+86-02-83062808'}], 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Wenhua Liang, MD', 'role': 'CONTACT', 'email': 'liangwh1987@163.com', 'phone': '+86-02-83062808'}], 'overallOfficials': [{'name': 'Wenhua Liang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jianxing He', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-08-09', 'type': 'RELEASE'}, {'date': '2024-10-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jianxing He, Professor, The First Affiliated Hospital of Guangzhou Medical University'}}}}