protocolSection identificationModule nctId: NCT06286631, orgStudyIdInfo id: Rating scale-202402, briefTitle: Prediction of Lymph Node Metastasis in Patients With Thyroid Malignancy by a New Scale, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Xi'an Jiaotong University, class: OTHER, descriptionModule briefSummary: The incidence of papillary thyroid cancer (PTC) has been on the rise in recent years, and 20%-50% of PTC patients will have lymph node metastasis. Lymph node involvement in PTC patients is usually related to the recurrence of PTC after surgery, and 30% of patients recur without lymph node dissection, with the risk of central cervical lymph node metastasis being the greatest, so it seems to be a good choice to perform lymph node dissection on patients after thyroidectomy, but in fact, there are controversies at home and abroad as to whether to perform lymph node dissection or not. The 2021 Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of differentiated thyroid cancer state that prophylactic central lymph node dissection (PCND) may increase the incidence of postoperative complications, but due to the high metastatic rate of PTC and the ability of PCND to effectively prevent recurrence and reoperation, countries in the East Asian region perform prophylactic lymph node dissection on almost all patients with PTC. However, for more countries in Europe and the United States, performing PCND has become a non-essential, individualized option. The aim of this study is to collect multifactorial data from more than 1,000 patients who have undergone previous thyroidectomy from 2021 to 2023, and to develop a novel scoring scale that can be used to individualize patients' scores based on a variety of factors prior to surgery, so that patients can be more accurately predicted to have lymph node metastasis and need prophylactic lymph node dissection prior to surgery, and patients who do not need dissection can avoid surgery. For patients who do not need lymph node dissection, complications caused by surgery can be avoided, while for patients who do have lymph node metastasis, recurrence of their cancer can be prevented. This will change the status quo of not being able to accurately determine the actual situation through simple preoperative examination or performing prophylactic lymph node dissection for all PTC patients., conditionsModule conditions: Papillary Thyroid Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Height, primaryOutcomes measure: Weight, primaryOutcomes measure: Age, primaryOutcomes measure: Genders, primaryOutcomes measure: BMI, primaryOutcomes measure: Whether lymph node dissection was performed during previous surgery, primaryOutcomes measure: Tumor Diameter Size, primaryOutcomes measure: Tumor limitation of the primary focus, primaryOutcomes measure: Extratumoral invasion, primaryOutcomes measure: Pathologic lymph node metastasis, primaryOutcomes measure: Tumor cystic solidity on preoperative ultrasound, primaryOutcomes measure: Preoperative ultrasound tumor echo intensity, primaryOutcomes measure: Preoperative ultrasound tumor boundaries, primaryOutcomes measure: Preoperative ultrasound tumor for the presence of calcifications, primaryOutcomes measure: Preoperative ultrasound tumor aspect ratios, primaryOutcomes measure: Preoperative ultrasound for enlarged cervical lymph nodes, primaryOutcomes measure: TSH, primaryOutcomes measure: TPOAb, primaryOutcomes measure: TgAb, primaryOutcomes measure: Calcium, primaryOutcomes measure: B-raf gene mutation, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Xi'an Jiaotong University, status: RECRUITING, city: Xi'an, state: Shaanxi, zip: 710000, country: China, contacts name: Yang Liu, doctor, role: CONTACT, phone: 0086+029-13384986500, email: individualliu@163.com, geoPoint lat: 34.25833, lon: 108.92861, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-29, uploadDate: 2024-02-22T03:07, filename: Prot_000.pdf, size: 79490, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-10-29, uploadDate: 2024-02-22T03:08, filename: ICF_001.pdf, size: 132491, hasResults: False