Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT03517267
Status:
UNKNOWN
Last Update Posted:
2018-08-31
First Post:
2018-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thyroid Imaging Reporting and Data System (TIRADS ) Versus Thyroid Association (ATA) Guidelines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2018-03-28', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of Risk stratifications', 'timeFrame': 'The outcome measures will be assessed within 1 year from the initiation of recruitment.', 'description': 'All nodules that will be aspirated , will be categorized according to the two risk stratification methods:\n\nThyroid Imaging Reporting and Data System (TIRADS) and the American Thyroid Association (ATA) guidelines. The cytology results will be documented in the form of Bethesda scoring The risk stratification results will be compared to the Cytology results that will be considered the gold standard for malignancy .\n\nAccuracy of each method will be calculated .'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Nodule']}, 'descriptionModule': {'briefSummary': 'Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on high-resolution ultrasound .Ultrasound used in order to differentiate between benign and malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US guided ( Fine needle aspiration ) FNA is known to be the test of choice in order to determine the nodules nature . Four to 6.5 % of all nodules are malignant .There are several guidelines that were suggested to help predict the risk stratification of thyroid nodules by ultrasound .\n\nThe American Thyroid Association (ATA) is widely used as evaluation, clinical and ultrasound criteria for fine-needle aspiration biopsy and management of thyroid nodules. The recent ACR TIRADS is a reporting system for thyroid nodules on ultrasound proposed by the American College of Radiology (ACR) published april 2017 that uses a slightly different scoring system for recommendation for FNA of thyroid.\n\nThe aim of this study is to validate TIRADS ACR 2017 risk stratification in the patient population in comparison to ATA risk stratification', 'detailedDescription': 'Thyroid nodules are a very common clinical problem with prevalence of up to 68% in adults on high-resolution ultrasound .Ultrasound used in order to differentiate between benign and malignant lesion in the thyroid has shown sensitivity of 93.8% and specificity of 66% and US guided ( Fine needle aspiration ) FNA is known to be the test of choice with sensitivity and specificity were 89.5% and 98%, respectively in order to determine the nodules nature, . Four to 6.5 % of all nodules are malignant .There are several guidelines that were suggested to help predict the risk stratification of thyroid nodules by ultrasound .\n\nThe American Thyroid Association (ATA) guidelines which characterized the nodule by its size, echogenicity, shape, presence or absence of calcification and evidence of Extrathyroidal extension (ETE) is widely use as evaluation, clinical and ultrasound criteria for fine-needle aspiration biopsy and management of thyroid nodules. These nodule characteristics classify the risk for malignancy into five categories which include benign pattern, very low suspicion pattern, low suspicion pattern, intermediate suspicious pattern and high suspicion pattern .\n\nThe recent ACR TIRADS is a reporting system for thyroid nodules on ultrasound proposed by the American College of Radiology (ACR) published april 2017 that uses a slightly different scoring system for recommendation for FNA of thyroid nodules .The ultrasound features set by TIRADS include composition, echogenicity, shape, margins and echogenic foci. The scoring range according suspicion of malignancy.\n\nThe aim of this study is to validate TIRADS ACR 2017 risk stratification in the patient population in comparison to ATA risk stratification.\n\nMethods\n\nThe study will be prospective Informed consent will be signed before the FNA All patients referred for thyroid nodule FNA from outpatient and in patient clinics over 18 will be included .\n\nThe nodule to undergo FNA will be chosen according to TIRADS ACR criteria and the ATA risk criteria ( if there is a disagreement between the methods whether to perform FNA the FNA will be performed ) If both methods do not recommend FNA , but the referring doctor has requested the procedure or the patient is unable to stay on follow up , the FNA will be performed .\n\nData will be collected according the table Cytological results using Bethesda scoring and surgery results, when applicable will be collected .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients referred for thyroid nodule FNA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients referred for thyroid nodule FNA from outpatient and in patient clinics\n* Patients older that 18\n\nExclusion Criteria:\n\n\\# Patients younger that 18'}, 'identificationModule': {'nctId': 'NCT03517267', 'briefTitle': 'Thyroid Imaging Reporting and Data System (TIRADS ) Versus Thyroid Association (ATA) Guidelines', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Validation of the New Thyroid Imaging Reporting and Data System (TIRADS) From 2017 Risk Assessment of Thyroid Nodules in Comparison to the American Thyroid Association (ATA) Guidelines From 2015', 'orgStudyIdInfo': {'id': ': RambamMC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ultrasound and FNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'The nodule to undergo FNA will be chosen according to TIRADS ACR criteria and the ATA risk criteria ( if there is a disagreement between the methods whether to perform FNA the FNA will be performed ) If both methods do not recommend FNA , but the referring doctor has requested the procedure or the patient is unable to stay on follow up , the FNA will be performed .'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'state': 'Israek', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'NIRA BECK-RAZI, md', 'role': 'CONTACT', 'email': 'n_beck_razi@rambam.health.gov.il', 'phone': '97247772664'}], 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'NIRA BECK-RAZI, MD', 'role': 'CONTACT', 'email': 'n_beck_razi@rambam.health.gov.il', 'phone': '97247772664'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Ultrasound Unit', 'investigatorFullName': 'razi-Beck Nira MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}