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Prediction of Lymph Node Metastasis in Patients With Thyroid Malignancy by a New Scale

Quantitative Rating Scale Based on Preoperative Prediction of Lymph Node Dissection in Patients With Thyroid Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06286631
Enrollment
800
Registered
2024-02-29
Start date
2023-05-01
Completion date
2026-10-01
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papillary Thyroid Cancer

Keywords

Papillary Thyroid Cancer, pre-operative, Prophylactic lymph node dissection, lymphatic node transfer, Multi-factor data

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Papillary thyroid cancer * Conscious and able to communicate normally * Age 16-80 years

Exclusion criteria

* Preoperative or postoperative pathology suggests other types of tumors, such as medullary carcinoma or undifferentiated carcinoma. * Less than 16 years of age

Design outcomes

Primary

MeasureTime frameDescription
BMIup to three yearsBMI will be summarized in kg/m\^2.
Heightup to three yearsThe height indicator will summarize the data in meters.
Weightup to three yearsThe weight indicator will summarize data in kilograms.
Ageup to three yearsAge will be aggregated using years as the unit of measurement.
Gendersup to three yearsData will be summarized in terms of male and female as units of measurement.
Whether lymph node dissection was performed during previous surgeryup to three yearsData will be summarized using yes or no for whether lymph node dissection was performed during previous surgery.
Tumor Diameter Sizeup to three yearsTumor diameter size will be summarized in millimeters.
Tumor limitation of the primary focusup to three yearsTumor limitation of primary foci will be summarized using single/multiple and unilateral/bilateral.
Extratumoral invasionup to three yearsExtra-tumor focal invasion will be summarized with a yes or no to the data.
Pathologic lymph node metastasisup to three yearsPathological lymph node metastases will be summarized with yes or no data.
Tumor cystic solidity on preoperative ultrasoundup to three yearsPre-operative ultrasound tumor cysticity will be summarized as cystic or solid.
Preoperative ultrasound tumor echo intensityup to three yearsPreoperative ultrasound tumor echo intensity will be summarized as high echo or moderate echo or low echo or very low echo.
Preoperative ultrasound tumor boundariesup to three yearsPreoperative ultrasound tumor boundaries will be summarized as clear or unclear.
Preoperative ultrasound tumor for the presence of calcificationsup to three yearsPreoperative ultrasound tumors will be summarized with yes or no for the presence of calcifications.
Preoperative ultrasound tumor aspect ratiosup to three yearsPreoperative ultrasound tumor aspect ratios will be summarized with \>1 or \<1 data
Preoperative ultrasound for enlarged cervical lymph nodesup to three yearsPreoperative ultrasound of cervical lymph nodes for enlargement will be summarized as yes or no.
TSHup to three yearsThe TSH indicator will summarize data in mlU/L.
TPOAbup to three yearsThe TPOAb indicator will summarize data in lU/mL.
TgAbup to three yearsThe TgAb indicator will summarize data in lU/mL.
Calciumup to three yearsThe Calcium indicator will summarize data in mmol/L.
B-raf gene mutationup to three yearsB-raf mutations will be summarized as wild type or mutant.

Countries

China

Contacts

Primary ContactYang Liu, doctor
individualliu@163.com0086+029-13384986500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026