Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-28 @ 4:42 AM
Study NCT ID:
NCT05721157
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2023-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D058866', 'term': 'Osteoporotic Fractures'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4912}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-07', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-01-31', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'newly diagnosed with osteoporosis', 'timeFrame': 'Within 180 days', 'description': 'After performing an chest X-ray, the osteoporosis was followed.'}], 'secondaryOutcomes': [{'measure': 'initiation of DXA examination', 'timeFrame': 'Within 180 days', 'description': 'After performing an chest X-ray, the osteoporosis was followed.'}, {'measure': 'initiation of anti-osteoporotic treatment', 'timeFrame': 'Within 180 days', 'description': 'After performing an chest X-ray, the osteoporosis was followed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis', 'Osteoporotic Fractures']}, 'descriptionModule': {'briefSummary': 'Artificial Intelligence-assisted Diagnosis and Prognostication in Osteoporosis Using Chest X-ray'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients recieved at least 1 chest X-ray examination in 2022\n* More than 66% chest X-ray identified as high risk of osteoporosis by AI-CXR\n\nExclusion Criteria:\n\n* Patients with history of at least 1 dual energy x-ray absorptiometry (DXA)\n* Patients with history of osteoporosis or osteoportic fracture\n* Patients recieved prescription anti-osteoporotic treatment (excluding vitamin D or calcium)\n* Patients died before 01 Jan 2023'}, 'identificationModule': {'nctId': 'NCT05721157', 'briefTitle': 'Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN)', 'organization': {'class': 'OTHER', 'fullName': 'National Defense Medical Center, Taiwan'}, 'officialTitle': 'Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN): a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NDMC2023001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients randomized to intervention will have access to the screening tool.', 'interventionNames': ['Other: AI-enabled Chest X-ray-based Screening Tool']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients randomized to control will continue routine practice.'}], 'interventions': [{'name': 'AI-enabled Chest X-ray-based Screening Tool', 'type': 'OTHER', 'description': 'Primary care clinicians in the intervention group had access to the report, which displayed whether the AI-Chest X-ray result was positive or negative.The system will send a message to corresponding physicians if positive finding.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11490', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-service general hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Defense Medical Center, Taiwan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chin Lin', 'investigatorAffiliation': 'National Defense Medical Center, Taiwan'}}}}