Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT03624751
Status:
RECRUITING
Last Update Posted:
2018-08-10
First Post:
2018-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow up for Patients With Thyroid Cancer Planed for Radioiodine Scan or Treatment
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': 'C000614965', 'term': 'Iodine-131'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2018-05-24', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Zung's Self-reported depression scale", 'timeFrame': '1 month', 'description': 'Depression symtpoms'}], 'secondaryOutcomes': [{'measure': 'Brain-derived neurotrophic factor', 'timeFrame': '1 month', 'description': 'BDNF'}, {'measure': 'orexin', 'timeFrame': '1 month', 'description': 'An associated factor for depression'}, {'measure': 'Body composition', 'timeFrame': '1 months', 'description': 'Fat component percentage to lean mass percentage ratio'}, {'measure': 'VCAM-1', 'timeFrame': '1 months', 'description': 'adhesion molecules'}, {'measure': 'CRP', 'timeFrame': '1 months', 'description': 'inflammation marker'}, {'measure': 'Metabolic syndrome', 'timeFrame': '1 months', 'description': 'The number of conponents for metabolic syndrome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'The prevalence of thyroid cancer has increased in recent decades. Patients with thyroid cancer need to choose between Thyrogen® injection and Eltroxin® withdrawal before radioiodine therapy or scan. This is a prospective, observational study, aiming to observe the difference of metabolic profiles between patients choose Thyrogen® injection and Eltroxin® withdrawal.', 'detailedDescription': '1. Objective： To observe the difference between Thyogen® injection or Eltroxin® withdrawal on metabolic profile.\n2. Background and method:： The prevalence of thyroid cancer has increased in recent decades. Patients with thyroid cancer need to choose between Thyrogen® injection and Eltroxin® withdrawal before radioiodine therapy or scan. This is a prospective, observational study, aiming to observe the difference of metabolic profiles between patients choose Thyrogen® injection and Eltroxin® withdrawal.\n\nInclusion ： Patient number: 500人\n\nInclusion criteria :\n\n1. Patients with diagnosis of thyroid cancer。\n2. Patients who need radioiodine therapy or scan。\n\nExclusion criteria:\n\n1. Patients cannot cooperate with blood test.。\n2. Patients cannot cooperate with radioiodine therapy。 Study design： Prospective, observational study。\n\nMethod： We will collect 20cc blood and 20 cc urine before and after radioiodine therapy during each visit (total 3 visits) and check lipid profiles, glucose profiles and inflammation markers. We will compare the difference between results of patients undergoing Thyrogen® injection and Eltroxin® withdrawal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosis of thyroid cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with diagnosis of thyroid cancer。\n2. Patients who need radioiodine therapy or scan。\n\nExclusion Criteria:\n\n1. Patients cannot cooperate with blood test.。\n2. Patients cannot cooperate with radioiodine therapy。'}, 'identificationModule': {'nctId': 'NCT03624751', 'briefTitle': 'Follow up for Patients With Thyroid Cancer Planed for Radioiodine Scan or Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Follow up for Patients With Thyroid Cancer Planed for Radioiodine Scan or Treatment', 'orgStudyIdInfo': {'id': 'CE18104A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'radioiodine', 'type': 'RADIATION', 'description': 'Patients with thyroid cancer need to choose between Thyrogen® injection and Eltroxin® withdrawal before radioiodine therapy or scan.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '407', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'I-Te Lee, MD', 'role': 'CONTACT', 'email': 'itlee@vghtc.gov.tw', 'phone': '886-4-23741340'}, {'name': 'I-Te Lee, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Division of Endocrinology and Metabolism in Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}