Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-03-27 @ 11:13 AM
Study NCT ID:
NCT02936804
Status:
UNKNOWN
Last Update Posted:
2016-10-19
First Post:
2016-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Diagnosis and Therapy for Early Stage Lung Cancer
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'}], '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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2016-10-15', 'studyFirstSubmitQcDate': '2016-10-15', 'lastUpdatePostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung cancer incidence rate', 'timeFrame': '5 years', 'description': 'Assess the number of lung cancer incidences after each round of screening. Compared the stage differences between screening arm and natural incidence.'}], 'secondaryOutcomes': [{'measure': 'Lung cancer disease free survival', 'timeFrame': '5 years', 'description': 'Compared the disease-free survival (DFS) among different treatment strategy of early stage lung cancer.'}, {'measure': 'Lung cancer mortality', 'timeFrame': '5 years', 'description': 'Assess lung cancer mortality within next 5 years after first round of screening'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['early stage lung cancer', 'LDCT screening', 'lung resection', 'electromagnetic navigation bronchoscopy', 'peripheral biomarker'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The present study is a single arm clinical trial aiming to improve the key technology in the diagnosis and treatment of early stage lung cancer. 60,000 high-risk subjects (age 45-70) are planned to recruit and assign to the Low Dose Computed Tomography (LDCT) screening arm (Baseline + 2 rounds of biennial repeated LDCT screening). Management of positive screening test will be carried out by a pre-specified protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Eligible participants were those aged 45-70 years, and with either of the following risk factors:\n\n1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;\n2. malignant tumors history in immediate family members;\n3. personal cancer history;\n4. professional exposure to carcinogens;\n5. long term exposure to second-hand smoke;\n6. 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': 'NCT02936804', 'briefTitle': 'Precision Diagnosis and Therapy for Early Stage Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Key Technology in Precision Diagnosis and Therapy for Early Stage Lung Cancer: a Single Arm Clinical Trial', 'orgStudyIdInfo': {'id': 'Chest002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening Arm', 'description': 'Low Dose Computed Tomography (LDCT) was performed at baseline + 2 rounds of biennial repeated LDCT. Management of positive screening test will be carried out by a pre-specified protocol.', 'interventionNames': ['Device: Low Dose Computed Tomography']}], 'interventions': [{'name': 'Low Dose Computed Tomography', 'type': 'DEVICE', 'description': 'LDCT was performed at baseline and 2 rounds of biennial repeated LDCT. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm. The management of abnormal nodules including precision diagnosis by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), electromagnetic navigation bronchoscope (ENB) and peripheral biomarkers, and precision therapy by intraoperative frozen section guided lung resection and ENB radiofrequency ablation.', 'armGroupLabels': ['Screening Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Baohui Han, MD,PhD', 'role': 'CONTACT', 'email': 'xkyyhan@gmail.com', 'phone': '86-21-62821990', 'phoneExt': '3301'}, {'name': 'Yanwei Zhang, MD,PhD', 'role': 'CONTACT', 'email': 'zhangyw198691@163.com', 'phone': '86-21-62821990', 'phoneExt': '3306'}], 'facility': 'Shanghai Chest hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Baohui Han, MD, PhD', 'role': 'CONTACT', 'email': 'xkyyhan@gmail.com', 'phone': '86-21-62821990', 'phoneExt': '3301'}, {'name': 'Yanwei Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'zhangyw198691@163.com', 'phone': '86-21-62821990', 'phoneExt': '3306'}], 'overallOfficials': [{'name': 'Baohui Han, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': ': Vice-President', 'investigatorFullName': 'Baohui Han', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}