Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT03179150
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2017-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation of the M5L Lung CAD
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Per-patient detection sensitivity unassisted vs CAD assisted reading', 'timeFrame': '1 month after collection of data', 'description': 'Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per patient analysis'}, {'measure': 'Per-lesion detection sensitivity unassisted vs CAD assisted reading', 'timeFrame': '1 month after collection of data', 'description': 'Comparison of the detection sensitivity between unassisted and CAD assisted reading. Per-lesion analysis. Sub-analyses per nodule tissue, nodule dimension and nodule localization are included'}], 'secondaryOutcomes': [{'measure': 'Comparison of reading time between unassisted vs CAD assisted reading', 'timeFrame': '1 month after collection of data'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['computer-aided diagnosis', 'Web', 'Cloud computing', 'lung cancer'], 'conditions': ['Lung Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'To compare the diagnostic performance and time efficiency of Computer-Aided Detection (CAD) assisted reading for the identification of pulmonary nodules in chest Computed Tomography (CT) from oncological patients with that of unassisted reading.', 'detailedDescription': 'The main aim of this study is to compare the diagnostic performance of CAD assisted interpretation with that of unassisted reading in the detection of lung metastases in consecutive patients staged for extrathoracic malignancies. This study also aims at validating a new Web/Cloud based workflow for the use of CAD systems in clinical practice, not requiring installation of additional software or hardware and potentially representing a cost-effective CAD solution for clinical facilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Between September 2015 and March 2016, 237 consecutive patients (123 men, 52%) with an average age of 62 (range 21-90 years), were enrolled in this retrospective observational single centre study. Patients enrolled into the study performed CT either for staging, restaging or follow-up of extrathoracic malignancies', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed extra-thoracic neoplasm\n\nExclusion Criteria:\n\n* More than 10 nodules\n* Severe pulmonary fibrosis\n* Diffuse bronchiectasis\n* Extensive inflammatory consolidation\n* Massive pleural effusion\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03179150', 'briefTitle': 'Clinical Validation of the M5L Lung CAD', 'organization': {'class': 'OTHER', 'fullName': 'Candiolo Cancer Institute - IRCCS'}, 'officialTitle': 'Clinical Validation of a CAD System for the Automated Identification of Pulmonary Metastases in Oncological Patients - CADM5L', 'orgStudyIdInfo': {'id': '35/2017 CADM5L'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oncological patients with extra-thoracic cancer', 'description': 'Patients enrolled into the study performed CT either for staging, restaging or follow-up of extrathoracic malignancies.', 'interventionNames': ['Diagnostic Test: Computed Tomography']}], 'interventions': [{'name': 'Computed Tomography', 'type': 'DIAGNOSTIC_TEST', 'description': 'CT scans were performed on a 128 detector rows CT scanner (Somatom Definition Flash Siemens Medical Systems, Erlangen, Germany) as in routine clinical practice in the centre', 'armGroupLabels': ['Oncological patients with extra-thoracic cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10060', 'city': 'Candiolo', 'state': 'Torino', 'country': 'Italy', 'facility': 'IRCCS Candiolo', 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Candiolo Cancer Institute - IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Alberto Traverso', 'investigatorAffiliation': 'Candiolo Cancer Institute - IRCCS'}}}}