Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
Study NCT ID:
NCT06733766
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2024-12-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Thermal Ablation for Recurrent 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020728', 'term': 'Transurethral Resection of Prostate'}], 'ancestors': [{'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2024-12-07', 'studyFirstSubmitQcDate': '2024-12-12', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of disease progression', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'cervical lymph node metastases and persistent tumors confirmed by pathology, Distant metastasis detected by CT, positron emission tomography, or bone scan if there were suspicious symptoms.'}], 'secondaryOutcomes': [{'measure': 'rate of complications', 'timeFrame': '1 week', 'description': 'complication of ablation'}, {'measure': 'rate of volume reduction', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'volume reduction of tumor after ablation on ultrasound and contrast-enhanced ultrasound'}, {'measure': 'rate of tumor disappearance', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound'}, {'measure': 'Tg level', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'serum thyroglobulin level'}, {'measure': 'rate of delayed surgery', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'patients underwent surgery after ablation because of anxiety'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the long-term outcomes of ultrasound-guided thermal ablation for recurrent thyroid cancer', 'detailedDescription': 'To evaluate and predict the long-term outcomes of ultrasound-guided thermal ablation for recurrent thyroid cancer by a multicenter study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with recurrent thyroid cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patient received thyroidectomy for thyroid cancer\n2. recurrent lesions were pathologically proven to be malignant by core-needle biopsy or fine needle aspiration\n3. no evidence of distant metastases.\n4. follow-up period ≥12 months\n\nExclusion Criteria:\n\n1. coagulation disorder, serious heart, respiratory, liver, or renal failure\n2. dysfunction of the vocal cord on the opposite side'}, 'identificationModule': {'nctId': 'NCT06733766', 'briefTitle': 'Ultrasound-guided Thermal Ablation for Recurrent Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Ultrasound-guided Thermal Ablation for Recurrent Thyroid Cancer: A Multicenter Study', 'orgStudyIdInfo': {'id': '2024-657'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ultrasound-guided thermal ablation', 'description': 'ultrasound-guided thermal ablation', 'interventionNames': ['Procedure: ultrasound-guided thermal ablation']}], 'interventions': [{'name': 'ultrasound-guided thermal ablation', 'type': 'PROCEDURE', 'description': 'microwave ablation, radiofrequency ablation, laser ablation', 'armGroupLabels': ['ultrasound-guided thermal ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Yan', 'role': 'CONTACT'}, {'name': 'Lin Yan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lin Yan', 'role': 'CONTACT', 'email': 'gemma-y@163.com', 'phone': '13811237313', 'phoneExt': '86'}], 'overallOfficials': [{'name': 'Yukun Luo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yu-kun Luo', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}