Prediction of Lymph Node Metastasis in Patients With Thyroid Malignancy by a New Scale
- Conditions
- Papillary Thyroid Cancer
- Registration Number
- NCT06286631
- Lead Sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Brief Summary
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.
- Detailed Description
1. Patient characteristics: the inclusion criteria were as follows:1. patients with papillary thyroid cancer;2. minimum age of 16 years old and maximum age of 80 years old. Exclusion criteria:1. age less than 16 years old;2. postoperative pathology suggesting that there are other types of tumors, such as medullary carcinoma or undifferentiated carcinoma. 2,.Data collection: Investigators collected multifactorial data on about 1000 patients who had undergone previous thyroidectomy from 2021-2023, including gender, height, age, weight, BMI, diameter of the tumor in the primary focus, tumor limitation in the primary focus, lymph node metastasis, and tumor invasion, preoperative ultrasonographic manifestations, preoperative laboratory results, pathological results, and genetic testing results. From these, the available data were screened and retained for analysis. 3.Data analysis: According to the retained data after screening, classical machine learning algorithms will be used for feature selection to select the factors with greater correlation with the results, and then with the help of data visualization, the specific quantitative relationship between each factor and the results will be determined according to the distribution of the available data, and the quantitative scoring table will be created. 4. Clinical validation: The completed quantitative rating scale investigators will be validated in the clinic. Investigators will use the scale to score new patients to assess whether participants need prophylactic lymph node dissection, and then evaluate the accuracy of the quantitative scale according to the intraoperative or postoperative situation.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Papillary thyroid cancer
- Conscious and able to communicate normally
- Age 16-80 years
- Preoperative or postoperative pathology suggests other types of tumors, such as medullary carcinoma or undifferentiated carcinoma.
- Less than 16 years of age
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight up to three years The weight indicator will summarize data in "kilograms".
Tumor cystic solidity on preoperative ultrasound up to three years Pre-operative ultrasound tumor cysticity will be summarized as "cystic" or "solid".
Preoperative ultrasound tumor echo intensity up to three years Preoperative ultrasound tumor echo intensity will be summarized as "high echo" or "moderate echo" or "low echo" or "very low echo".
Preoperative ultrasound tumor aspect ratios up to three years Preoperative ultrasound tumor aspect ratios will be summarized with "\>1" or "\<1" data
TgAb up to three years The TgAb indicator will summarize data in "lU/mL".
Calcium up to three years The Calcium indicator will summarize data in "mmol/L".
Height up to three years The height indicator will summarize the data in "meters".
Age up to three years Age will be aggregated using "years" as the unit of measurement.
BMI up to three years BMI will be summarized in "kg/m\^2".
TSH up to three years The TSH indicator will summarize data in "mlU/L".
Pathologic lymph node metastasis up to three years Pathological lymph node metastases will be summarized with "yes" or "no" data.
Genders up to three years Data will be summarized in terms of "male" and "female" as units of measurement.
Whether lymph node dissection was performed during previous surgery up to three years Data will be summarized using "yes" or "no" for whether lymph node dissection was performed during previous surgery.
Tumor Diameter Size up to three years Tumor diameter size will be summarized in "millimeters".
Tumor limitation of the primary focus up to three years Tumor limitation of primary foci will be summarized using "single/multiple" and "unilateral/bilateral".
Preoperative ultrasound tumor boundaries up to three years Preoperative ultrasound tumor boundaries will be summarized as "clear" or "unclear".
Preoperative ultrasound for enlarged cervical lymph nodes up to three years Preoperative ultrasound of cervical lymph nodes for enlargement will be summarized as "yes" or "no".
TPOAb up to three years The TPOAb indicator will summarize data in "lU/mL".
B-raf gene mutation up to three years B-raf mutations will be summarized as "wild type" or "mutant".
Extratumoral invasion up to three years Extra-tumor focal invasion will be summarized with a "yes" or "no" to the data.
Preoperative ultrasound tumor for the presence of calcifications up to three years Preoperative ultrasound tumors will be summarized with "yes" or "no" for the presence of calcifications.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China