Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-28 @ 6:03 AM
Study NCT ID:
NCT05752604
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2023-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Conventional Treatments and Clinical Variables on Thyroid Cancer
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2042-03-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-03-01', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-03-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic risk stratification', 'timeFrame': 'one year from the primary treatment', 'description': 'impact of the different variables on the DRS'}, {'measure': 'Dynamic risk stratification', 'timeFrame': 'five years from the primary treatment', 'description': 'impact of the different variables on the DRS'}, {'measure': 'Dynamic risk stratification', 'timeFrame': 'ten years from the primary treatment', 'description': 'impact of the different variables on the DRS'}, {'measure': 'Progression-free survival', 'timeFrame': 'one year from the primary treatment', 'description': 'impact of the different variables on the PFS in patients treated with TKI for advanced thyroid cancer'}, {'measure': 'Progression-free survival', 'timeFrame': 'five years from the primary treatment', 'description': 'impact of the different variables on the PFS in patients treated with TKI for advanced thyroid cancer'}, {'measure': 'Progression-free survival', 'timeFrame': 'ten years from the primary treatment', 'description': 'impact of the different variables on the PFS in patients treated with TKI for advanced thyroid cancer'}, {'measure': 'Overall survival', 'timeFrame': 'one year from the primary treatment', 'description': 'impact of the different variables on the OS in patients treated with TKI for advanced thyroid cancer'}, {'measure': 'Overall survival', 'timeFrame': 'five years from the primary treatment', 'description': 'impact of the different variables on the OS in patients treated with TKI for advanced thyroid cancer'}, {'measure': 'Overall survival', 'timeFrame': 'ten years from the primary treatment', 'description': 'impact of the different variables on the OS in patients treated with TKI for advanced thyroid cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'DTC has a generally favorable prognosis. The possibility to discriminate between patients with aggressive tumors and those with a more indolent behavior may reduce the need for unnecessary treatments. Aim of this observational study is to evaluate how anamnestic, clinical, and histopathological variables may influence the outcome of the enrolled patients, both regarding morbidity and mortality and in terms of therapeutic choices. The study aims to evaluate the prognostic impact of the therapeutic interventions in terms of efficacy and regarding the appearance of adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all consecutive patients referred to our tertiary clinical center for thyroid cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- thyroid cancer diagnosis\n\nExclusion Criteria:\n\n* patients unable to sign informed consent'}, 'identificationModule': {'nctId': 'NCT05752604', 'acronym': 'THY-CANC', 'briefTitle': 'Impact of Conventional Treatments and Clinical Variables on Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Retrospective and Prospective Evaluation of the Impact of Innovative and Conventional Treatments and of Clinical Variables on the Outcome of Thyroid Cancer', 'orgStudyIdInfo': {'id': '05C212'}}, 'contactsLocationsModule': {'locations': [{'zip': '20149', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Laura Fugazzola, MD', 'role': 'CONTACT', 'email': 'l.fugazzola@auxologico.it', 'phone': '+3902619112727'}], 'facility': 'Istituto Auxologico Italiano, IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Laura Fugazzola, MD', 'role': 'CONTACT', 'email': 'l.fugazzola@auxologico.it', 'phone': '+390261911', 'phoneExt': '2727'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}