Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT04904159
Status:
UNKNOWN
Last Update Posted:
2021-06-01
First Post:
2021-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scoring System for Thyroid Gland Pathologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}, {'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'}, {'id': 'D038481', 'term': 'Anterior Temporal Lobectomy'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-27', 'studyFirstSubmitDate': '2021-05-17', 'studyFirstSubmitQcDate': '2021-05-22', 'lastUpdatePostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age', 'timeFrame': 'Before Surgery', 'description': 'Years'}, {'measure': 'Gender', 'timeFrame': 'Before Surgery', 'description': 'Male - Female'}, {'measure': 'Smoking Status', 'timeFrame': 'Before Surgery', 'description': 'Yes or No'}, {'measure': 'Radiation to the Neck Area', 'timeFrame': 'Before Surgery', 'description': 'Yes or No'}, {'measure': 'History of Thyroiditis', 'timeFrame': 'Before Surgery', 'description': 'Yes or No'}, {'measure': 'Family History', 'timeFrame': 'Before Surgery', 'description': 'Presence of family members with any thyroid pathologies especially thyroid cancer'}, {'measure': 'Complaint', 'timeFrame': 'Before Surgery', 'description': 'Months'}, {'measure': 'Thyroid Imaging Reporting and Data System ( TIRADS ) score', 'timeFrame': 'Before surgery', 'description': 'Radiological features of throid nodule ( minimum value is 1 maximum value is 5 ); thyroid nodule which has a higher value means a worse outcome'}, {'measure': 'Bethesda classification system for thyroid fine needle aspirates', 'timeFrame': 'Before surgery', 'description': 'Histopathological features of thyroid nodule ( minimum value is 1 maximum value is 6 ) thyroid nodule which has higher value means a worse outcome'}, {'measure': 'Thyroid Stimulating Hormone ( TSH ) levels', 'timeFrame': 'Before surgery', 'description': 'it is a hormone secreted from the pituitary gland and triggers the functioning of the thyroid gland ( cut of values are 0.5 - 5.0 mIU / L )'}, {'measure': 'Pathology results', 'timeFrame': 'Immediately after the surgery', 'description': 'The result of the throid gland part sent to the pathology unit after surgery ( the results can be benign or malign )'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TI-RADS', 'Bethesda'], 'conditions': ['Thyroid Nodule', 'Thyroid Cancer']}, 'referencesModule': {'references': [{'pmid': '25388058', 'type': 'BACKGROUND', 'citation': 'Macias CA, Arumugam D, Arlow RL, Eng OS, Lu SE, Javidian P, Davidov T, Trooskin SZ. A risk model to determine surgical treatment in patients with thyroid nodules with indeterminate cytology. Ann Surg Oncol. 2015 May;22(5):1527-32. doi: 10.1245/s10434-014-4190-8. Epub 2014 Nov 12.'}, {'pmid': '31552809', 'type': 'BACKGROUND', 'citation': 'Ianni F, Pascucci D, Paragliola RM, Rota CA, Perotti G, Fadda G, Pontecorvi A, Corsello SM. Follow-Up or Surgery for Indeterminate Thyroid Nodules: Could the CUT Score Application Be a Support for Decision-Making in the Preoperative Assessment? Thyroid. 2020 Jan;30(1):65-71. doi: 10.1089/thy.2018.0649. Epub 2019 Oct 23.'}, {'pmid': '33599836', 'type': 'BACKGROUND', 'citation': 'Sparano C, Verdiani V, Pupilli C, Perigli G, Badii B, Vezzosi V, Mannucci E, Maggi M, Petrone L. Choosing the best algorithm among five thyroid nodule ultrasound scores: from performance to cytology sparing-a single-center retrospective study in a large cohort. Eur Radiol. 2021 Aug;31(8):5689-5698. doi: 10.1007/s00330-021-07703-5. Epub 2021 Feb 18.'}, {'pmid': '33660454', 'type': 'BACKGROUND', 'citation': 'Shin HS, Na DG, Paik W, Yoon SJ, Gwon HY, Noh BJ, Kim WJ. Malignancy Risk Stratification of Thyroid Nodules with Macrocalcification and Rim Calcification Based on Ultrasound Patterns. Korean J Radiol. 2021 Apr;22(4):663-671. doi: 10.3348/kjr.2020.0381. Epub 2021 Feb 2.'}, {'pmid': '32733383', 'type': 'BACKGROUND', 'citation': "Madeo B, Brigante G, Ansaloni A, Taliani E, Kaleci S, Monzani ML, Simoni M, Rochira V. The Added Value of Operator's Judgement in Thyroid Nodule Ultrasound Classification Arising From Histologically Based Comparison of Different Risk Stratification Systems. Front Endocrinol (Lausanne). 2020 Jul 7;11:434. doi: 10.3389/fendo.2020.00434. eCollection 2020."}, {'pmid': '32100197', 'type': 'BACKGROUND', 'citation': 'Cozzolino A, Pozza C, Pofi R, Sbardella E, Faggiano A, Isidori AM, Giannetta E, Pernazza A, Rullo E, Ascoli V, Lenzi A, Gianfrilli D. Predictors of malignancy in high-risk indeterminate (TIR3B) cytopathology thyroid nodules. J Endocrinol Invest. 2020 Aug;43(8):1115-1123. doi: 10.1007/s40618-020-01200-0. Epub 2020 Feb 25.'}, {'pmid': '24930423', 'type': 'BACKGROUND', 'citation': 'Maia FF, Matos PS, Pavin EJ, Zantut-Wittmann DE. Thyroid imaging reporting and data system score combined with Bethesda system for malignancy risk stratification in thyroid nodules with indeterminate results on cytology. Clin Endocrinol (Oxf). 2015 Mar;82(3):439-44. doi: 10.1111/cen.12525. Epub 2014 Jul 7.'}, {'pmid': '25747526', 'type': 'BACKGROUND', 'citation': 'Remonti LR, Kramer CK, Leitao CB, Pinto LC, Gross JL. Thyroid ultrasound features and risk of carcinoma: a systematic review and meta-analysis of observational studies. Thyroid. 2015 May;25(5):538-50. doi: 10.1089/thy.2014.0353. Epub 2015 Mar 31.'}, {'pmid': '29703794', 'type': 'BACKGROUND', 'citation': 'Chaigneau E, Russ G, Royer B, Bigorgne C, Bienvenu-Perrard M, Rouxel A, Leenhardt L, Belin L, Buffet C. TIRADS score is of limited clinical value for risk stratification of indeterminate cytological results. Eur J Endocrinol. 2018 Jul;179(1):13-20. doi: 10.1530/EJE-18-0078. Epub 2018 Apr 27.'}]}, 'descriptionModule': {'briefSummary': 'Although anamnesis and physical examination remain the place in the evaluation of patients today; laboratory values, imaging methods and pathology results have come to the fore in the decision-making of surgery for patients. As a result of all other criteria, a follow-up decision can be changed in a patient with a single fine needle aspiration biopsy result, or despite all the examinations the investigators have, a clear result cannot be achieved, and patient management may be disrupted. A holistic approach to thyroid gland pathologies is planned thanks to the scoring system that will be created in this study.', 'detailedDescription': 'In routine clinical practice, the criteria the investigators consider during the pre - op period in patients evaluated due to thyroid pathologies include anamnesis, physical examination, laboratory values, especially thyroid function, thyroid-neck ultrasonographies, fine needle aspiration biopsies, according to which decisions about operation or nonoperative follow-up are made with the patient. The investigators aim to create a common scoring system by taking into account the pathology results of patients who have undergone thyroidectomy and comparing these results with the results of pre-op examination and thus to address patient management in a more objective and comprehensive way.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Thyroidectomy, which is a routine operation in clinic ( unilateral, total, complementary, etc.) ) applied patients will be included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who undergone surgery for thyroid gland pathologies\n\nExclusion Criteria:\n\n* patients who did not want to be involved in the study\n* patients who missed in the follow-up period\n* pregnant patients'}, 'identificationModule': {'nctId': 'NCT04904159', 'briefTitle': 'Scoring System for Thyroid Gland Pathologies', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}, 'officialTitle': 'A New Scoring System in the Diagnosis of Thyroid Gland Pathologies', 'orgStudyIdInfo': {'id': '2021/514/198/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Benign', 'description': 'Patients who have benign pathologies after thyroidectomy', 'interventionNames': ['Procedure: Lobectomy']}, {'label': 'Malign', 'description': 'Patients who have malign pathologies after thyroidectomy', 'interventionNames': ['Procedure: Thyroidectomy']}], 'interventions': [{'name': 'Thyroidectomy', 'type': 'PROCEDURE', 'description': 'total thyroidectomy', 'armGroupLabels': ['Malign']}, {'name': 'Lobectomy', 'type': 'PROCEDURE', 'description': 'Lobectomy', 'armGroupLabels': ['Benign']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34890', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kartal Dr Lutfi Kirdar Tranining and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Hasan Fehmi Küçük, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul Dr. Lutfi Kirdar Kartal Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ramazan Sari', 'investigatorAffiliation': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}}}}