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

NCT06286631 | Recruiting

• 1 other identifier: Rating scale-202402
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Papillary Thyroid Cancer

Keywords

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

Outcome Measures

Primary Outcomes (21)

• Height

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

  up to three years

• Weight

  The weight indicator will summarize data in "kilograms".

  up to three years

• Age

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

  up to three years

• Genders

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

  up to three years

• BMI

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

  up to three years

• Whether lymph node dissection was performed during previous surgery

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

  up to three years

• Tumor Diameter Size

  Tumor diameter size will be summarized in "millimeters".

  up to three years

• Tumor limitation of the primary focus

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

  up to three years

• Extratumoral invasion

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

  up to three years

• Pathologic lymph node metastasis

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

  up to three years

• Tumor cystic solidity on preoperative ultrasound

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

  up to three years

• Preoperative ultrasound tumor echo intensity

  Preoperative ultrasound tumor echo intensity will be summarized as "high echo" or "moderate echo" or "low echo" or "very low echo".

  up to three years

• Preoperative ultrasound tumor boundaries

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

  up to three years

• Preoperative ultrasound tumor for the presence of calcifications

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

  up to three years

• Preoperative ultrasound tumor aspect ratios

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

  up to three years

• Preoperative ultrasound for enlarged cervical lymph nodes

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

  up to three years

• TSH

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

  up to three years

• TPOAb

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

  up to three years

• TgAb

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

  up to three years

• Calcium

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

  up to three years

• B-raf gene mutation

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

  up to three years

Study Arms (2)

Past Medical Records Group

Sample size:500 Whether control group:No Name of exposure factor:papillary thyroid cancer Exposure factor type:Other Description of exposure factor:None

Clinical Validation Group

Sample size:300 Whether control group:No Name of exposure factor:papillary thyroid cancer Exposure factor type:Other Description of exposure factor:None

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

From 2021 to 2023, 500 patients with previous papillary thyroid cancer surgery were selected at the Second Affiliated Hospital of Xi'an Jiaotong University for the quantitative rating scale, as well as 300 newly admitted papillary thyroid cancer patients for subsequent validation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

RECRUITING

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yang Liu, doctor

CONTACT

0086+029-13384986500; individualliu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 29, 2024
• Study Start: May 1, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

CN (1)