Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-29 @ 12:26 PM
Study NCT ID:
NCT05851404
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2023-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Indeterminate Thyroid Nodules Across Different World Regions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013965', 'term': 'Thyroidectomy'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-01', 'studyFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2023-05-01', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of malignancy', 'timeFrame': '36 months', 'description': 'Number of cancers over the total patients submitted to thyroidectomy for indeterminate thyroid nodules'}, {'measure': 'Surgical approach to indeterminate thyroid nodules', 'timeFrame': '36 months', 'description': 'Number of lobectomies over the total patients submitted to thyroidectomy for indeterminate thyroid nodules'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Indeterminate thyroid nodule', 'Thyroid carcinoma'], 'conditions': ['Indeterminate Thyroid Nodules']}, 'descriptionModule': {'briefSummary': 'Thyroid carcinoma (TC) is the most common endocrine malignancy, affecting 0.2-1.5% of individuals worldwide. The rising incidence rate of TC is mostly related to the expanding use of high-quality imaging techniques, with an increase in the detection of thyroid nodules. Fine needle aspiration cytology (FNAC) is the most accurate, rapid, safe, and cost-effective test for the evaluation of thyroid nodules, with high specificity and sensitivity. Nevertheless, FNAC is particularly unreliable in differentiating between benign and malignant nodules that fall under the category of indeterminate thyroid nodules (class III and class IV according to Bethesda Classification\\[2\\]). In fact, in these cases, the expected malignancy rates are 5-15% and 15-30%, respectively. Thus, most patients with indeterminate thyroid nodules undergo an operation that is indeed unnecessary, while representing a risk for surgical complications and a cost for health-care systems.\n\nWe aim to evaluate different approaches to indeterminate nodules across different countries in the world.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We aim to investigate different approaches to indeterminate thyroid nodules across different countries worldwide', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Bethesda III / Bethesda IV thyroid nodules\n\nExclusion Criteria:\n\n* Patients with preoperative diagnosis of lymph node metastases'}, 'identificationModule': {'nctId': 'NCT05851404', 'briefTitle': 'Management of Indeterminate Thyroid Nodules Across Different World Regions', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'officialTitle': 'Management of Indeterminate Thyroid Nodules Across Different World Regions: a Multicentric International Study', 'orgStudyIdInfo': {'id': 'UNICA-MEDAS-23-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'South East Asian Region (SEAR)', 'description': 'Patients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR', 'interventionNames': ['Procedure: Thyroidectomy']}, {'label': 'Americas Region (AMR)', 'description': 'Patients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR', 'interventionNames': ['Procedure: Thyroidectomy']}, {'label': 'Eastern Mediterranean Region (EMR)', 'description': 'Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR', 'interventionNames': ['Procedure: Thyroidectomy']}, {'label': 'the Europe Region (EUR)', 'description': 'Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR', 'interventionNames': ['Procedure: Thyroidectomy']}, {'label': 'Western Pacific Region (WPR)', 'description': 'Patients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR', 'interventionNames': ['Procedure: Thyroidectomy']}], 'interventions': [{'name': 'Thyroidectomy', 'type': 'PROCEDURE', 'description': 'Total thyroidectomy or lobectomy', 'armGroupLabels': ['Americas Region (AMR)', 'Eastern Mediterranean Region (EMR)', 'South East Asian Region (SEAR)', 'Western Pacific Region (WPR)', 'the Europe Region (EUR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09100', 'city': 'Cagliari', 'state': 'CA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Medas, MD', 'role': 'CONTACT', 'email': 'fabiomedas@unica.it', 'phone': '+393206836288'}], 'facility': 'AOU Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Fabio Medas', 'investigatorAffiliation': 'University of Cagliari'}}}}