Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2026-01-20 @ 3:53 PM
Study NCT ID:
NCT05962892
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Factors Influencing Recurrence After Thermal Ablation of Papillary Thyroid Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-07-19', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the recurrence of PTC', 'timeFrame': '1 to 5 years', 'description': 'the recurrence of PTC during follow-up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Papillary Thyroid Carcinoma', 'cohort', 'Thermal Ablation', 'Recurrence'], 'conditions': ['Papillary Thyroid Carcinoma', 'Thermal Ablation']}, 'descriptionModule': {'briefSummary': 'A prospective cohort of papillary thyroid carcinoma(PTC), patients who received thermal ablation in our hospital since February 2023 was established as the study object. Preoperative and postoperative demographic data, ultrasonography, other relevant laboratory tests, and thyroid disease-related scales such as fatigue, depression, and stress were collected. The influencing factors of PTC recurrence were analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pathologically proven PTC underwent ultrasound-guided percutaneous thermal ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n①≥18 years old; ② Obtain informed consent; ③ Ultrasonography showed that malignant nodules were single, the maximum diameter of nodules was ≤1cm and the distance from the capsule was ≥2mm. ④ no lymph node metastasis or other extra-glandular metastasis in the neck; ⑤ PTC was confirmed by fine needle puncture pathology; ⑥ Patients who do not meet Article 3, who still strongly request thermal ablation while fully informing the patient of the risk of recurrence, and who have been clinically assessed to be technically capable of thermal ablation Exclusion Criteria:① Pregnant or lactating patients; ② Patients with other malignant tumors and not suitable for ablation by clinical evaluation; ③ Patients who cannot tolerate surgery; ④ Patients with cognitive impairment and other conditions who cannot accurately fill in thyroid-related questionnaires.'}, 'identificationModule': {'nctId': 'NCT05962892', 'briefTitle': 'A Study of Factors Influencing Recurrence After Thermal Ablation of Papillary Thyroid Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'A Study of Factors Influencing Recurrence After Thermal Ablation of Papillary Thyroid Carcinoma', 'orgStudyIdInfo': {'id': 'MR-11-23-009728'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Intervention', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['No Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianquan Shi', 'role': 'CONTACT', 'email': 'sonoshixq@ccmu.edu.cn', 'phone': '18510085125'}], 'facility': 'Beijing Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xianquan Shi, PhD', 'role': 'CONTACT', 'email': 'sonoshixq@ccmu.edu.cn', 'phone': '18510085125'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}