Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT01130402
Status:
COMPLETED
Last Update Posted:
2010-05-26
First Post:
2010-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Real-time and Computerized Sonographic Reporting System in Predicting Malignant Cervical Lymphadenopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072281', 'term': 'Lymphadenopathy'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-25', 'studyFirstSubmitDate': '2010-05-24', 'studyFirstSubmitQcDate': '2010-05-25', 'lastUpdatePostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The final diagnoses of lymph nodes were made by US-FNA cytological studies, pathologic results of the biopsy specimens, or at least 3 months of negative follow-up observations.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['age', 'lymphadenopathy', 'fine needle aspiration', 'sonography'], 'conditions': ['Lymphadenopathy']}, 'referencesModule': {'references': [{'pmid': '19693943', 'type': 'RESULT', 'citation': 'Liao LJ, Wang CT, Young YH, Cheng PW. Real-time and computerized sonographic scoring system for predicting malignant cervical lymphadenopathy. Head Neck. 2010 May;32(5):594-8. doi: 10.1002/hed.21225.'}]}, 'descriptionModule': {'briefSummary': 'The investigaotors want to establish a real-time and computerized score reporting system based on the significant predictors of the measured sonographic parameters and demographic data.', 'detailedDescription': 'One hundred eight patients with neck lymphadenopathy, receiving ultrasonography and ultrasound-guided fine-needle aspiration (US-FNA), were used to construct a predictive model. This model was validated by another independent patient cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '83 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with previously untreated neck masses were referred for sonographic evaluation and subsequent US-FNA after informed consent was obtained. Demographic data, including age and sex, side, site, and number of lymphadenopathy was collected as well.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with previously untreated neck masses underwent neck US\n\nExclusion Criteria:\n\n* The neck mass was not lymph node\n* No US-FNA cytology result'}, 'identificationModule': {'nctId': 'NCT01130402', 'briefTitle': 'A Real-time and Computerized Sonographic Reporting System in Predicting Malignant Cervical Lymphadenopathy', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'A Real-time and Computerized Sonographic Scoring System for Predicting Malignant Cervical Lymphadenopathy', 'orgStudyIdInfo': {'id': '098026-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neck masses', 'description': 'Patients with previously untreated neck masses'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22050', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Li-Jen Liao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Research Ethics Review Committee', 'oldOrganization': 'Far Eastern Memorial Hospital, Taipei, Taiwan'}}}}