Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04000620
Status:
UNKNOWN
Last Update Posted:
2021-11-16
First Post:
2019-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imaging-based Deep Learning for Lung Cancer Diagnosis and Staging
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': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2019-06-24', 'studyFirstSubmitQcDate': '2019-06-24', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pathologic result revealed cancer cell involvement in lesion', 'timeFrame': '1 month after the pathologic test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Lung cancer diagnosis and staging are two fundamental and critical issue in clinical lung cancer management and therapeutic decision-making. Invasive procedures for pathologic analysis are gold standard for diagnosis and staging, however, invasive procedures related-complications are inevitable. Noninvasive medical imaging is a powerful tool, however there is almost no room for improvement just according to the experience of radiologist and clinician. The researchers will investigate the role of computer based deep learning of medical imaging in the diagnosis of lesion of lung, lymph node and other sites suspected with metastasis.', 'detailedDescription': 'Radiologist'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lung cancer patients with PET/CT or CT examination before any cancer-specific treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological diagnosis of lung cancer\n* PET/CT or CT examination before any cancer-specific treatment\n\nExclusion Criteria:\n\n* A history of other malignancies'}, 'identificationModule': {'nctId': 'NCT04000620', 'briefTitle': 'Imaging-based Deep Learning for Lung Cancer Diagnosis and Staging', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'The Role of CNN Architecture-based Transfer Learning of Medical Imaging in Lung Cancer Diagnosis and Staging', 'orgStudyIdInfo': {'id': 'AFDSFA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cancer cell involvement predicted by deep learning', 'description': 'the participants with lesions of lung, lymph node or other sites predicted as positive for cancer cell involvement by imaging based deep learning.', 'interventionNames': ['Procedure: surgery', 'Procedure: punture']}, {'label': 'no cancer cell involvement predicted by deep learning', 'description': 'the participants with lesions of lung, lymph node or other sites predicted as negative for cancer cell involvement by imaging based deep learning.', 'interventionNames': ['Procedure: surgery', 'Procedure: punture']}], 'interventions': [{'name': 'surgery', 'type': 'PROCEDURE', 'description': 'treatment intent surgery', 'armGroupLabels': ['cancer cell involvement predicted by deep learning', 'no cancer cell involvement predicted by deep learning']}, {'name': 'punture', 'type': 'PROCEDURE', 'description': 'diagnostic punture', 'armGroupLabels': ['cancer cell involvement predicted by deep learning', 'no cancer cell involvement predicted by deep learning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhilei Lv, MD', 'role': 'CONTACT', 'email': '794646434@qq.com', 'phone': '86-15107177084'}], 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Zhilei Lv, MD', 'role': 'CONTACT', 'email': '794646434@qq.com', 'phone': '86-15107177084'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yang Jin', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}