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NCT Number: NCT06286631

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

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.

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Key information

Conditions

Papillary Thyroid Cancer Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location status: Recruiting

Location contact

Yang Liu, doctor

CONTACT

[email protected]

0086+029-13384986500

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Height

    Time frame: up to three years

    The height indicator will summarize the data in "meters".

  2. Weight

    Time frame: up to three years

    The weight indicator will summarize data in "kilograms".

  3. Age

    Time frame: up to three years

    Age will be aggregated using "years" as the unit of measurement.

  4. Genders

    Time frame: up to three years

    Data will be summarized in terms of "male" and "female" as units of measurement.

  5. BMI

    Time frame: up to three years

    BMI will be summarized in "kg/m^2".

  6. Whether lymph node dissection was performed during previous surgery

    Time frame: up to three years

    Data will be summarized using "yes" or "no" for whether lymph node dissection was performed during previous surgery.

  7. Tumor Diameter Size

    Time frame: up to three years

    Tumor diameter size will be summarized in "millimeters".

  8. Tumor limitation of the primary focus

    Time frame: up to three years

    Tumor limitation of primary foci will be summarized using "single/multiple" and "unilateral/bilateral".

  9. Extratumoral invasion

    Time frame: up to three years

    Extra-tumor focal invasion will be summarized with a "yes" or "no" to the data.

  10. Pathologic lymph node metastasis

    Time frame: up to three years

    Pathological lymph node metastases will be summarized with "yes" or "no" data.

  11. Tumor cystic solidity on preoperative ultrasound

    Time frame: up to three years

    Pre-operative ultrasound tumor cysticity will be summarized as "cystic" or "solid".

  12. Preoperative ultrasound tumor echo intensity

    Time frame: 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".

  13. Preoperative ultrasound tumor boundaries

    Time frame: up to three years

    Preoperative ultrasound tumor boundaries will be summarized as "clear" or "unclear".

  14. Preoperative ultrasound tumor for the presence of calcifications

    Time frame: up to three years

    Preoperative ultrasound tumors will be summarized with "yes" or "no" for the presence of calcifications.

  15. Preoperative ultrasound tumor aspect ratios

    Time frame: up to three years

    Preoperative ultrasound tumor aspect ratios will be summarized with ">1" or "<1" data

  16. Preoperative ultrasound for enlarged cervical lymph nodes

    Time frame: up to three years

    Preoperative ultrasound of cervical lymph nodes for enlargement will be summarized as "yes" or "no".

  17. TSH

    Time frame: up to three years

    The TSH indicator will summarize data in "mlU/L".

  18. TPOAb

    Time frame: up to three years

    The TPOAb indicator will summarize data in "lU/mL".

  19. TgAb

    Time frame: up to three years

    The TgAb indicator will summarize data in "lU/mL".

  20. Calcium

    Time frame: up to three years

    The Calcium indicator will summarize data in "mmol/L".

  21. B-raf gene mutation

    Time frame: up to three years

    B-raf mutations will be summarized as "wild type" or "mutant".

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Liu, doctor

CONTACT

[email protected]

0086+029-13384986500

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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