Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-03 @ 12:43 PM
Study NCT ID:
NCT06124469
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2023-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UNN-RADS Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}, 'targetDuration': '21 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2023-11-06', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'metastatic lymph node', 'timeFrame': 'All biopsy samples were sent to the pathology department of the unit, where final results were obtained in approximately 2-3 weeks.', 'description': 'Fine needle aspiration biopsy (FNA) results were the gold standard (metastatic or benign).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymph node', 'Thyroid cancer', 'Ultrasonography', 'Metastasis'], 'conditions': ['Thyroid Cancer', 'Lymph Node']}, 'referencesModule': {'references': [{'pmid': '27070179', 'type': 'RESULT', 'citation': 'Ryu KH, Lee KH, Ryu J, Baek HJ, Kim SJ, Jung HK, Kim SM. Cervical Lymph Node Imaging Reporting and Data System for Ultrasound of Cervical Lymphadenopathy: A Pilot Study. AJR Am J Roentgenol. 2016 Jun;206(6):1286-91. doi: 10.2214/AJR.15.15381. Epub 2016 Apr 12.'}, {'pmid': '15855141', 'type': 'RESULT', 'citation': 'Ahuja AT, Ying M. Sonographic evaluation of cervical lymph nodes. AJR Am J Roentgenol. 2005 May;184(5):1691-9. doi: 10.2214/ajr.184.5.01841691.'}, {'pmid': '29031367', 'type': 'RESULT', 'citation': 'Prativadi R, Dahiya N, Kamaya A, Bhatt S. Chapter 5 Ultrasound Characteristics of Benign vs Malignant Cervical Lymph Nodes. Semin Ultrasound CT MR. 2017 Oct;38(5):506-515. doi: 10.1053/j.sult.2017.05.005. Epub 2017 May 20.'}, {'pmid': '36038830', 'type': 'RESULT', 'citation': 'Ni X, Xu S, Zhan W, Zhou W. Ultrasonographic features of cervical lymph node metastases from medullary thyroid cancer: a retrospective study. BMC Med Imaging. 2022 Aug 29;22(1):151. doi: 10.1186/s12880-022-00882-7.'}, {'pmid': '21547389', 'type': 'RESULT', 'citation': 'Meyer JE, Steffen A, Bienemann M, Hedderich J, Schulz U, Laudien M, Quetz J, Wollenberg B. Evaluation and development of a predictive model for ultrasound-guided investigation of neck metastases. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):315-20. doi: 10.1007/s00405-011-1611-1. Epub 2011 May 6.'}, {'type': 'RESULT', 'citation': 'Sarda Inman ED, Valdez Rojas AM. Ultrasound Neck Node Reporting and Data System (UNN-RADS) for lymphadenopathy: A structured report. J Mex Fed Radiol Imaging 2022;3:151-163.'}]}, 'descriptionModule': {'briefSummary': 'In 2020, Sarda-Inman et al., developed the Ultrasound Neck Node Reporting and Data System (UNN-RADS) scale that allows decision-making about when it is appropriate to perform FNA of a cervical lymph node, evaluating seven ultrasonographic descriptors (shape, margins, echogenicity, echogenicity of the hilum, vascularity and the presence/absence of calcifications, and cystic degeneration), features that have been associated with metastatic lymph nodes, with scores ranging from 0 to 3 points, which allows categorize into 5 different risk groups. Thus, the objective of this study is to evaluate the ultrasound characteristics of metastatic LN in patients undergoing TC follow-up and to validate the UNN-RADS scale for the diagnosis of LN Metastasis in Patients with a history of TC.', 'detailedDescription': 'This study enrolled consecutive patients in follow-up for differentiated thyroid cancer (DTC) history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes. Patients were included if they 1) had previous history of DTC, 2) both sexes with age over 18 years old, and 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1. Patients were excluded if they underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer, had previous bilateral cervical lymph node dissection as initial treatment, or the FNA results were not concluded.\n\nUNN-RADS 1 y 2 and UNN-RADS 3, 4 and 5 were grouped for analysis purpose. Diagnostic performance of UNN-RADS scale were assessed in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), positive likelihood ratios (+LR), negative likelihood ratios (-LR) and accuracy, as well as with a receiver operating characteristic (ROC) curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes at Unidad Médica de Alta Especialidad HE 1 CMN Bajío', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) had previous history of DTC 2) both sexes with age over 18 years old 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1\n\nExclusion Criteria:\n\n* 1\\) underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer 2) had previous bilateral cervical lymph node dissection as initial treatment 3) FNA results were not concluded'}, 'identificationModule': {'nctId': 'NCT06124469', 'briefTitle': 'UNN-RADS Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Mexicano del Seguro Social'}, 'officialTitle': 'Validation of The Ultrasound Neck Node Reporting and Data System (UNN-RADS) Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer', 'orgStudyIdInfo': {'id': '3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Benign lymph nodes', 'description': 'Categories UNN-RADS 1 and 2 (test negative)', 'interventionNames': ['Diagnostic Test: US-guided fine needle aspiration (FNA)']}, {'label': 'Metastatic lymph nodes', 'description': 'Categories UNN-RADS 3, 4, and 5 (test positive).', 'interventionNames': ['Diagnostic Test: US-guided fine needle aspiration (FNA)']}], 'interventions': [{'name': 'US-guided fine needle aspiration (FNA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'This study enrolled consecutive patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical', 'armGroupLabels': ['Benign lymph nodes', 'Metastatic lymph nodes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37260,', 'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'facility': 'Unidad Medica de Alta Especialidad No. 1, Bajío', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}], 'overallOfficials': [{'name': 'Hilda Maciaqs, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto Mexicano del Seguro Social'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '1 month', 'ipdSharing': 'YES', 'description': 'The datasets generated or analyzed during the study are available from the principal investigator on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Hilda Elizabeth Macías Cervantes', 'investigatorAffiliation': 'Instituto Mexicano del Seguro Social'}}}}