Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-26 @ 9:05 AM
Study NCT ID:
NCT06316895
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2024-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}], 'ancestors': [{'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 3772}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2024-02-16', 'studyFirstSubmitQcDate': '2024-03-16', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of disease progression', 'timeFrame': 'more than 5 year', 'description': 'cervical lymph node metastases, recurrent tumors and persistent tumors'}], 'secondaryOutcomes': [{'measure': 'Rate of complications', 'timeFrame': '1week', 'description': 'surgery or ablation complications'}, {'measure': 'Rate of tumor disappearance', 'timeFrame': '2 year', 'description': 'complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Papillary Thyroid Cancer']}, 'descriptionModule': {'briefSummary': '1. To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;\n2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with low-risk papillary thyroid carcinoma who choose surgery or thermal ablation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients age between 18 and 80 year old, both sex\n2. papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration\n3. the largest diameter ≤2.0 cm\n4. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, nech and chest CT\n5. follow-up period ≥12 months,\n\nExclusion Criteria:\n\n1. patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy\n2. history of neck radiation\n3. history of thyroid surgery\n4. coagulation disorder\n5. serious heart, respiratory, liver, or renal failure\n6. dysfunction of the vocal cord on the opposite side'}, 'identificationModule': {'nctId': 'NCT06316895', 'briefTitle': 'The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Low-risk Papillary Thyroid Carcinoma', 'orgStudyIdInfo': {'id': 'S2023-706'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'surgery group', 'description': 'patients with low-risk papillary thyroid carcinoma who chose thyroid surgery', 'interventionNames': ['Procedure: thyroid surgery']}, {'label': 'ablation group', 'description': 'patients with low-risk papillary thyroid carcinoma who chose thermal ablation', 'interventionNames': ['Procedure: ultrasound-guided thermal ablation']}], 'interventions': [{'name': 'thyroid surgery', 'type': 'PROCEDURE', 'description': 'thyroid lobectomy', 'armGroupLabels': ['surgery group']}, {'name': 'ultrasound-guided thermal ablation', 'type': 'PROCEDURE', 'description': 'radiofrequency ablation; microwave ablation or laser ablation', 'armGroupLabels': ['ablation group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lin Yan, MD', 'role': 'CONTACT', 'email': 'gemma-y@163.com', 'phone': '13811237313', 'phoneExt': '86'}], 'overallOfficials': [{'name': 'Yukun Luo', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Department of Ultrasound', 'investigatorFullName': 'Yu-kun Luo', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}