Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-28 @ 9:21 AM
Study NCT ID:
NCT06463392
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Learning-based sbORN Diagnostic Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 312}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-06-12', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The number of white blood cells in the peripheral blood.', 'timeFrame': 'Baseline'}, {'measure': 'The number of neutrophils in the peripheral blood.', 'timeFrame': 'Baseline'}, {'measure': 'The number of basophils in the peripheral blood.', 'timeFrame': 'Baseline'}, {'measure': 'The number of eosinophils in the peripheral blood.', 'timeFrame': 'Baseline'}, {'measure': 'The number of red blood cells in the peripheral blood.', 'timeFrame': 'Baseline'}, {'measure': 'The concentration of albumin in the peripheral blood.', 'timeFrame': 'Baseline'}, {'measure': 'The concentration of total protein in the peripheral blood.', 'timeFrame': 'Baseline'}, {'measure': 'The history of diabetes mellitus.', 'timeFrame': 'Baseline'}, {'measure': 'The history of hypertension.', 'timeFrame': 'Baseline'}, {'measure': 'The copy number of Epstein-Barr Virus (EBV) DNA.', 'timeFrame': 'Baseline'}, {'measure': 'The titer of EBV VCA IgA.', 'timeFrame': 'Baseline'}, {'measure': 'The titer of EBV EBNA1 IgA.', 'timeFrame': 'Baseline'}, {'measure': 'The titer of EBV EA IgA.', 'timeFrame': 'Baseline'}], 'primaryOutcomes': [{'measure': 'Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.', 'timeFrame': 'Baseline'}, {'measure': 'Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.', 'timeFrame': 'Baseline'}, {'measure': 'Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.', 'timeFrame': 'Baseline'}, {'measure': 'F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.', 'timeFrame': 'Baseline'}, {'measure': 'Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.', 'timeFrame': 'Baseline'}, {'measure': 'Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.', 'timeFrame': 'Baseline'}, {'measure': 'Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.', 'timeFrame': 'Baseline'}, {'measure': 'Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.', 'timeFrame': 'Baseline'}, {'measure': 'F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.', 'timeFrame': 'Baseline'}, {'measure': 'Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.', 'timeFrame': 'Baseline'}, {'measure': 'Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.', 'timeFrame': 'Baseline'}, {'measure': 'Dice similarity coefficient of the MRI contouring between the deep-learning-based multimodal model and the radiologists.', 'timeFrame': 'Baseline'}, {'measure': 'Average surface distance of the MRI contouring between the deep-learning-based multimodal model and the radiologists.', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal Carcinoma', 'Skull-base Osteonecrosis', 'Radiotherapy', 'Epstein-Barr Virus'], 'conditions': ['Nasopharyngeal Carcinoma', 'Herpesvirus 4, Human']}, 'descriptionModule': {'briefSummary': 'Skull-base osteonecrosis (sbORN) is a severe long-term complication of nasopharyngeal carcinoma (NPC) post radiotherapy, which significantly diminish the quality of life, increase the risk of internal carotid artery rupture, and is frequently misdiagnosed as NPC recurrence. Novel diagnostic tools are therefore clinically significant. In this study, the investigators seek to ask if a deep-learning-based model shows a significantly higher sensitivity than radiologists. With a cross-sectional design, the investigators aim to recruit 312 participants in Sun Yat-sen Memorial Hospital, Guangzhou, China that meet the eligibility criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All populations that meet the eligibility criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Equal to or older than 18 years old.\n* A history of histologically confirmed nonkeratinizing undifferentiated nasopharyngeal carcinoma.\n* A history of radical radiotherapy at nasopharynx.\n* Complete remission six months post radical radiotherapy according to RECIST 1.1.\n* No evidence of distant metastasis upon recruitment.\n* Diagnosis of sbORN given by senior radiologist with 2-4 Likert scores.\n* Consent to biopsy awake or under general anesthesia.\n* Consent to perform blood tests, EBV DNA, EBV IgAs, and MRI inspection of nasopharynx and neck.\n* With a written consent.\n\nExclusion Criteria:\n\n* MRI artifacts or other factors that interfere radiological diagnosis and region of interest contouring.\n* Suspected lesion is not confined to nasopharynx and skull-base.'}, 'identificationModule': {'nctId': 'NCT06463392', 'briefTitle': 'Deep Learning-based sbORN Diagnostic Model', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Development of Deep-Learning-Based Multimodal Post Radiotherapy Skull-Base Osteonecrosis and Recurrence of Nasopharyngeal Carcinoma Differential Diagnostic Model', 'orgStudyIdInfo': {'id': 'SYSKY-2024-395-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': 'Histologically confirmed sbORN that meets the eligibility criteria.', 'interventionNames': ['Other: No Intervention: Observational Cohort']}, {'label': 'Control', 'description': 'Histologically confirmed NPC recurrence that meets the eligibility criteria.', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'No intervention is scheduled for this observational study.', 'armGroupLabels': ['Case', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang-Wei Kong, Ph.D.', 'role': 'CONTACT', 'email': 'kongxw8@mail.sysu.edu.cn', 'phone': '0086-020-34071439'}], 'facility': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiang-Wei Kong, Ph.D.', 'role': 'CONTACT', 'email': 'kongxw8@mail.sysu.edu.cn', 'phone': '0086-020-34071439'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}