Comparing microwave ablation and surgery for low-risk papillary thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness and prognosis of ultrasound-guided microwave ablation (MWA) compared to surgical treatment for patients with low-risk papillary thyroid carcinoma (PTC). It focuses on the role of genetic mutations in treatment selection, utilizing next-generation sequencing to confirm low-risk status before treatment. A total of 201 patients diagnosed with PTC will be monitored until November 2024, with efficacy and complications assessed through long-term follow-up using ultrasound techniques.

Why it matters

Who can join: the full rules

The inclusion criteria of this study were as followed:

1. PTC confirmed by fine-needle aspiration (FNA);
2. Confirmed low-risk mutation types by next-generation sequencing (NGS) before surgery;
3. No severe functional diseases, such as heart failure, severe respiratory diseases, or renal failure;
4. Availability of complete follow-up data.

The exclusion criteria were as followed:

1. No local or distant metastasis assessed by imaging evaluations, including ultrasound or computed tomography (CT);
2. Lacking of preoperative genetic testing or inability to assess genetic test results;
3. Inability to complete follow-up or lost to follow-up during the study.

Low-risk PTC is defined as:

1. Maximum tumor diameter ≤1 cm;
2. Solitary lesion;
3. No local or distant metastasis;
4. No tumor invasion into extrathyroidal tissues;
5. No vascular invasion;
6. Non-invasive pathological subtype for the primary lesion (invasive subtypes include tall cell, columnar cell, diffuse sclerosing, solid/trabecular, and oncocytic vari ants);
7. No history of head and neck radiotherapy during adolescence;
8. No family history of thyroid cancer;
9. Genetic testing showing BRAF V600E mutation (without concurrent TERT mutation), RAS family gene mutations, (HRAS, NRAS, KRAS), or other low-risk mutations, such as isolated RET/PTC) rearrangements.

Intermediate-high risk PTC is defined as:

1. Maximum tumor diameter \>1 cm;
2. Multifocal thyroid cancer;
3. Local or distant metastasis;
4. Primary lesion with extrathyroidal extension;
5. Vascular invasion;
6. Primary lesion with an invasive pathological subtype;
7. History of head and neck radiotherapy during adolescence;
8. Family history of thyroid cancer;
9. Genetic testing revealing high-risk mutation combinations, such as BRAF V600E or RAS mutations with concurrent TERT or TP53 mutations, or RAS mutations combined with EIF1AX mutations.

Where it's running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Miaoyun Long, MD
• Email: longmy@mail.sysu.edu.cn
• Phone: 86-34070602

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.