Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT04197960
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2019-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microwave Ablation and Surgical Resection for Micropapillary 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 973}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2019-12-04', 'studyFirstSubmitQcDate': '2019-12-11', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local tumor progression', 'timeFrame': '2-year', 'description': 'the number of patients with tumor progression around the treated area'}, {'measure': 'lymph node metastasis', 'timeFrame': '2-year', 'description': 'the number of patients with lymph node metastasis'}, {'measure': 'distant metastasis', 'timeFrame': '2-year', 'description': 'the number of patients with thyroid cancer metastasizing to distant tissues or organs'}, {'measure': 'New thyroid cancer', 'timeFrame': '2-year', 'description': 'the number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland'}, {'measure': 'Disease progression', 'timeFrame': '2-year', 'description': 'the number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.'}], 'secondaryOutcomes': [{'measure': 'complication rate', 'timeFrame': '2-year', 'description': 'complication rate encouned during or after procedures'}, {'measure': 'blood loss', 'timeFrame': '2-year', 'description': 'the volume of blood loss during procedures'}, {'measure': 'free thyroxine', 'timeFrame': '2-year', 'description': 'change of free thyroxine concentration'}, {'measure': 'free triiodothyronine', 'timeFrame': '2-year', 'description': 'change of free triiodothyronine concentration'}, {'measure': 'thyroid-stimulating hormone', 'timeFrame': '2-year', 'description': 'change of thyroid-stimulating hormone concentration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Papillary Thyroid Carcinoma', 'Microwave ablation', 'Surgical resection'], 'conditions': ['Papillary Thyroid Carcinoma']}, 'referencesModule': {'references': [{'pmid': '36880949', 'type': 'DERIVED', 'citation': 'Zheng L, Dou JP, Han ZY, Liu FY, Yu J, Cheng ZG, Yu XL, Wang H, Cong ZB, Wang SR, Yu MA, Xu ZF, Che Y, Nan B, Liu C, Hao Y, Wang X, Liu Y, Zhou Y, Liang P. Microwave Ablation for Papillary Thyroid Microcarcinoma with and without US-detected Capsule Invasion: A Multicenter Prospective Cohort Study. Radiology. 2023 May;307(3):e220661. doi: 10.1148/radiol.220661. Epub 2023 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'The study aimed to compare the efficacy and safety of papillary thyroid microcarcinoma (PTMC) treated with microwave ablation(MWA) and surgery resection (SR), and to explore the tumor characteristics suitable for each treatment methods (such as with and without capsular invasion). The investigators organized 18 hospitals to participate in this multicenter study. Patients meeting following indications will be included in this study: 1. Biopsy pathology proved PTMC, but not high-risk subtype; 2. solitary mPTC, without US-detected gross extrathyroid extension; 3. no evidence of metastasis; 4 willing to participate in this study and perform regular follow-up. Patients themselves decide to receive MWA or SR for mPTC after medical consultation. Baseline characteristic including age, gender, thyroid function et al. will be collected. The treatment protocols of MWA and SR were according to the Chinese and international guidelines. The primary outcomes were the disease progression, including local tumor recurrence, lymph node metastasis, and distant metastasis. The secondary outcomes include thyroid function, complication rate, blood loss et al. Investigators will follow up enrolled patients and collect and upload data according to the trial. Treatment outcomes of tumor with and without US-detected capsular invasion was analyzes as subgroups.', 'detailedDescription': 'The treatment protocols of MWA and SR were according to the Chinese and international guidelines. MWA need to ablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule. SR basic protocol is lobectomy. All patients need to receive levothyroxine therapy to keep TSH lower than 0.5 mU/L. Patients in both groups underwent regular medical imaging and laboratory tests 1 month, 3-month, 6-month, 12-month, 18-month, 24-month and 36-month after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy pathology proved micropapillary thyroid carcinoma(mPTC), but not high-risk subtype\n* Solitary mPTC, without US-detected gross extrathyroid extension\n* No evidence of metastasis\n* Willing to participate in this study and perform regular follow-up\n\nExclusion Criteria:\n\n* Severe blood coagulation dysfunction (platelet count \\< 50x109/L cells or INR\\>1.5)\n* Acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction\n* Poor control of blood pressure(systolic pressure≥150mmHg or diastolic pressure≥95mmHg)\n* Poor control of blood glucose(fasting glucose\\>10mmol/L)\n* The opposite vocal cords dysfunction\n* Diagnosed with other malignant tumors\n* Pregnant and lactating women\n* Other conditions that investigator believe are not appropriate to be enrolled'}, 'identificationModule': {'nctId': 'NCT04197960', 'briefTitle': 'Microwave Ablation and Surgical Resection for Micropapillary Thyroid Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'A Prospective Multicenter Study to Compare the Therapeutic Outcomes of Microwave Ablation With Surgical Resection for Micropapillary Thyroid Carcinoma', 'orgStudyIdInfo': {'id': '301jrcsk-lp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'microwave ablation', 'description': 'ablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule.', 'interventionNames': ['Procedure: Microwave ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'surgical resection', 'description': 'thyroid lobectomy, total thyroidectomy, central lymph node dissection', 'interventionNames': ['Procedure: Surgical resection']}], 'interventions': [{'name': 'Microwave ablation', 'type': 'PROCEDURE', 'description': 'Use thermal energy to destroy tumor', 'armGroupLabels': ['microwave ablation']}, {'name': 'Surgical resection', 'type': 'PROCEDURE', 'description': 'Resect tumors', 'armGroupLabels': ['surgical resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Ping Liang', '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': 'Professor', 'investigatorFullName': 'Ping Liang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}