Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT05796960
Status:
UNKNOWN
Last Update Posted:
2023-04-04
First Post:
2023-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
European Multicenter Study on Surgical Management of Advanced Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}, {'id': 'C572845', 'term': 'Thyroid cancer, follicular'}, {'id': 'D018276', 'term': 'Carcinoma, Medullary'}, {'id': 'D065646', 'term': 'Thyroid Carcinoma, Anaplastic'}], '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': 'D000231', 'term': 'Adenocarcinoma, Papillary'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013965', 'term': 'Thyroidectomy'}, {'id': 'D008197', 'term': 'Lymph Node Excision'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3917}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survival, recurrence and mortality', 'timeFrame': 'January 2015-January 2021', 'description': 'Descriptive analysis of overall survival, recurrence and mortality in patients undergoing surgery for advanced thyroid cancer in European centers.'}], 'primaryOutcomes': [{'measure': 'Perioperative characteristics', 'timeFrame': 'January 2015-January 2021', 'description': 'Descriptive analysis of surgical perioperative characteristics of patients undergoing surgery for advanced thyroid cancer in European centers.'}], 'secondaryOutcomes': [{'measure': 'Short-term clinical outcomes', 'timeFrame': 'January 2015-January 2021', 'description': 'Descriptive analysis of short-term clinical outcomes of patients undergoing surgery for advanced thyroid cancer in European centers in terms of RLN palsy, critical neurovascular injury and voice changes through otorhinolaryngologist and clinical post-operative evaluation'}, {'measure': 'Short-term clinical outcomes', 'timeFrame': 'January 2015-January 2021', 'description': 'Descriptive analysis of short-term clinical outcomes of patients undergoing surgery for advanced thyroid cancer in European centers in terms of surgical complications, such as bleeding, lymphorrea tracheal or oesophageal injury (detected through clinical and/or imaging evaluation).'}, {'measure': 'Short-term clinical outcomes', 'timeFrame': 'January 2015-January 2021', 'description': 'Descriptive analysis of short-term clinical outcomes of patients undergoing surgery for advanced thyroid cancer in European centers in terms of hypocalcemia, hypoparathormonemia (detected through clinical and/or laburatoristic evaluation).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroid carcinoma', 'Eurocrine', 'Surgical management', 'Stage IV'], 'conditions': ['Thyroid Carcinoma', 'Thyroid Cancer', 'Thyroid Neoplasms', 'Thyroid Cancer, Papillary', 'Thyroid Cancer, Follicular', 'Thyroid Medullary Carcinoma', 'Anaplastic Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'The main aim of the study is to evaluate peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in patients undergoing surgery for advanced thyroid cancer in different European centers using the EUROCRINE® database.', 'detailedDescription': 'The incidence of thyroid cancer has risen exponentially over the last decades among developed countries. Even though this is mainly attributed to small well differentiated carcinomas (DTC) with excellent prognosis, the rates of advanced disease have also elevated. While the characteristics of advanced thyroid cancer are intuitively recognized by experienced surgeons of the field, a common definition among scientific societies is yet to be reached. The four main features of advanced cancer are locally and regionally advanced disease, distant metastasis, and recurrence. Guidelines for the optimal treatment of advanced disease are mainly included in the broader guidelines of each cancer subtype, such as the American Thyroid Association (ATA) guidelines for DTC, Medullary Thyroid Carcinoma (MTC) and most recently Anaplastic Thyroid Carcinoma (ATC). In the European setting, the European Society for Medical Oncology (ESMO) 2019 guidelines on thyroid cancer include a subsection for the management of advanced disease of each thyroid cancer type. A common limitation among published guidelines is the moderate to low level of evidence upon which the advanced disease recommendations are based; however, broad consensus has been reached regarding the paramount importance of surgery if an R0/R1 resection is achievable. Recently, new advances in targeted therapy guided by genetic alterations found in the tumor have provided new treatment options for patients; therefore, latest guidelines encourage the inclusion of patients with advanced disease in these clinical trials. Finally, neoadjuvant therapy modalities are constantly gaining ground with promising results allowing a greater portion of patients to benefit from surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with final histology of advanced thyroid carcinoma operated among European centers that participate in the Eurocrine® database between 2015 and 2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult (18 years old and older) patients\n* underwent surgery\n* final histology of advanced thyroid carcinoma\n* among European centers that participate in the Eurocrine® database between 2015 and 2021\n\nExclusion Criteria:\n\n* Patients \\<18 years old'}, 'identificationModule': {'nctId': 'NCT05796960', 'acronym': 'ATCEU', 'briefTitle': 'European Multicenter Study on Surgical Management of Advanced Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'European Multicenter Study on Perioperative Management, Operative Strategy, Morbidity, and Outcomes of the Surgical Management of Advanced Thyroid Cancer: (EUROCRINE® Study Group).', 'orgStudyIdInfo': {'id': '4999'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical operations for advanced thyroid cancer', 'description': 'All adult (18 years old and older) patients registered in EUROCRINE® database with stage IV thyroid cancer, M1, N1b, or T3b and above will be included', 'interventionNames': ['Procedure: Thyroidectomy with or without lymphadenectomy or multivisceral resection']}], 'interventions': [{'name': 'Thyroidectomy with or without lymphadenectomy or multivisceral resection', 'type': 'PROCEDURE', 'description': "Lymph node dissection, as well as its surgical extension, was performed according to the surgeon's discretion. Multivisceral operations involved oesophagus, trachea and larynx.", 'armGroupLabels': ['Surgical operations for advanced thyroid cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Sessa, Dr', 'role': 'CONTACT', 'email': 'luca.sessa@policlinicogemelli.it', 'phone': '34045218', 'phoneExt': '+39'}, {'name': 'Francesco Pennestrì, Dr', 'role': 'CONTACT', 'email': 'francesco.pennestri@policlinicogemelli.it', 'phone': '3280244528', 'phoneExt': '+39'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Luca Sessa, Dr', 'role': 'CONTACT', 'email': 'luca.sessa@policlinicogemelli.it', 'phone': '3934045218', 'phoneExt': '+39'}, {'name': 'Francesco Pennestrì, Dr', 'role': 'CONTACT', 'email': 'francesco.pennestri@policlinicogemelli.it', 'phone': '3280244528', 'phoneExt': '+39'}], 'overallOfficials': [{'name': 'Marco Raffaelli, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Reasonable requests will be evaluated by the Eurocrine Council'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}