Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 9:32 AM
Study NCT ID:
NCT07078032
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial Evaluating the Effectiveness of a Novel Risk-Stratified Screening Strategy for Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-12', 'studyFirstSubmitDate': '2025-07-12', 'studyFirstSubmitQcDate': '2025-07-12', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Predictive Value (PPV) of Screening Strategies', 'timeFrame': 'From enrollment through completion of diagnostic confirmation (up to 3 months post-screening)', 'description': 'Proportion of true lung cancer cases among participants with positive screening results, confirmed by histopathology within 3 months after screening. Calculated as: (True Positives) / (True Positives + False Positives) × 100%. Assessed separately for both screening arms.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of Screening Strategies', 'timeFrame': 'From screening to 12-month follow-up', 'description': 'Proportion of true lung cancer cases correctly identified by screening, confirmed through histopathology within 6 months. Calculated as: True Positives / (True Positives + False Negatives) × 100%. Includes interval cancers detected within 12 months post-screening'}, {'measure': 'Specificity of Screening Strategies', 'timeFrame': 'From screening to 12-month follow-up', 'description': 'Proportion of cancer-free participants correctly identified as screening-negative. Calculated as: True Negatives / (True Negatives + False Positives) × 100%. Cancer-free status confirmed by 12-month follow-up'}, {'measure': 'Negative Predictive Value (NPV)', 'timeFrame': 'From screening to 12-month follow-up', 'description': 'Proportion of screening-negative participants without lung cancer. Calculated as: True Negatives / (True Negatives + False Negatives) × 100%. Absence of cancer confirmed by 12-month follow-up including LDCT and clinical evaluation.'}, {'measure': 'Early-Stage Shift Proportion', 'timeFrame': 'At time of cancer diagnosis (within 3 months post-positive screening)', 'description': 'Percentage of screen-detected lung cancer cases diagnosed at early stage (AJCC 8th ed. Stage I-II) versus late stage (Stage III-IV). Calculated as: (Early-stage cases) / (Total screen-detected cases) × 100%.'}, {'measure': 'Lung Cancer-Specific Mortality Rate', 'timeFrame': 'From randomization to 3-year follow-up', 'description': 'Death rate attributable to lung cancer, verified by independent mortality review committee using ICD-10 codes (C34.0-C34.9) and medical records. Expressed as deaths per 1,000 person-years.'}, {'measure': 'Overall Survival in Screen-Detected Lung Cancer', 'timeFrame': 'From cancer diagnosis to 3-year follow-up', 'description': 'Time from pathological diagnosis of lung cancer to death from any cause. Assessed using Kaplan-Meier method with censoring at last follow-up. Reported as median survival with 95% CI.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer Screening']}, 'descriptionModule': {'briefSummary': 'A nationwide population-based multi-center RCT enrolling ≥60,000 eligible residents to compare screening effectiveness between risk-prediction-model-driven and traditional guideline-based high-risk lung cancer screening strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Residents with local household registration residing continuously in the region for ≥3 years.\n2. Aged 40-74 years at enrollment.\n\nExclusion Criteria:\n\n1. Prior diagnosis of lung cancer (histologically/cytologically confirmed)\n2. Currently receiving active treatment for any malignancy.\n3. Presence of severe comorbidities with life expectancy \\<5 years\n4. Participation in any lung cancer screening program within 5 years.\n5. Functional dependency (ADL score ≤2) OR unwillingness to comply with protocol-required follow-up.\n6. Declined to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT07078032', 'briefTitle': 'A Randomized Controlled Trial Evaluating the Effectiveness of a Novel Risk-Stratified Screening Strategy for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'A Randomized Controlled Trial Evaluating the Effectiveness of a Novel Risk-Stratified Screening Strategy for Lung Cancer', 'orgStudyIdInfo': {'id': '20250711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prediction Model Arm', 'description': 'Lung Cancer Risk Prediction Model Arm', 'interventionNames': ['Diagnostic Test: Prediction Model Arm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Screening Arm', 'description': 'Traditional High-Risk Factors Arm', 'interventionNames': ['Diagnostic Test: Standard Screening Arm']}], 'interventions': [{'name': 'Prediction Model Arm', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Lung Cancer Risk Prediction Model Arm'], 'description': 'Lung cancer risk stratification via prediction model integrating: advanced age, lung cancer family history, personal cancer history, childhood coal exposure, asthma history, and food allergy history. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases.', 'armGroupLabels': ['Prediction Model Arm']}, {'name': 'Standard Screening Arm', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Traditional High-Risk Factors Arm'], 'description': 'Participants are screened based on NCCN guideline criteria. High-risk individuals receive LDCT screening. Thoracic physicians guide management of screen-positive cases.', 'armGroupLabels': ['Standard Screening Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wenhua Liang professor, doctor', 'role': 'CONTACT', 'email': 'liangwh1987@163.com', 'phone': '+86 020-83062808'}, {'name': 'Huiting Wang', 'role': 'CONTACT', 'email': 'wangh1805657064@163.com', 'phone': '+86 15622132598'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jianxing He', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}