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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-80
SponsorSecond Affiliated Hospital of Xi'an Jiaotong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Papillary thyroid cancer

Conscious and able to communicate normally

Age 16-80 years

Disqualifiers

Preoperative or postoperative pathology suggests other types of tumors, such as medullary carcinoma or undifferentiated carcinoma.

Less than 16 years of age

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

800 Participants
are grouped into 2 trial groups
Group A: Past Medical Records Group
Group B: Clinical Validation Group

Trial outcomes

Primary outcomes

1

Height

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

Time frame
up to three years
2

Weight

The weight indicator will summarize data in "kilograms".

Time frame
up to three years
3

Age

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

Time frame
up to three years
4

Genders

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

Time frame
up to three years

Secondary outcomes

Other outcomes

Sponsors and contacts

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