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NCT06725576Recruiting

Ultrasound-Guided Microwave Ablation Vs. Surgery for Low-Risk PapilaryThyroid Carcinoma

Ultrasound and Gene-Guided Microwave Ablation Versus Surgery for Low-Risk Papillary Thyroid Carcinoma: a Prospective Observational Cohort Study.

Source: ClinicalTrials.gov · Last updated 31 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study aims to investigate the efficacy and prognosis of ultrasound-guided and gene-based microwave ablation (MWA) versus surgical treatment in patients with low-risk papillary thyroid carcinoma (PTC). By analyzing genetic testing results, the study explores the impact of genetic mutations on treatment selection for low-risk patients, providing more precise molecular biological evidence for treatment choices and prognosis evaluation of thyroid cancer. This prospective study collects clinical data from patients diagnosed with PTC at Sun Yat-sen Memorial Hospital of Sun Yat-sen University between January 2022 and November 2024, who underwent genetic testing prior to treatment, and assesses efficacy and complications through long-term follow-up.

Status (registry)
Recruiting
Study type
Observational
Enrollment
201 (estimated)
First submitted
5 Dec 2024
Start date
1 Jan 2022
Primary completion date
4 Mar 2025
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NCT number
NCT06725576

What you commit to

  • Study type: Observational
  • Planned participants: 201
  • From 1 Jan 2022 to the primary completion date, 4 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • The inclusion criteria of this study were as followed:
  • PTC confirmed by fine-needle aspiration (FNA);
  • Confirmed low-risk mutation types by next-generation sequencing (NGS) before surgery;
  • No severe functional diseases, such as heart failure, severe respiratory diseases, or renal failure;
  • Availability of complete follow-up data.
    • The exclusion criteria were as followed:
  • No local or distant metastasis assessed by imaging evaluations, including ultrasound or computed tomography (CT);
  • Lacking of preoperative genetic testing or inability to assess genetic test results;
  • Inability to complete follow-up or lost to follow-up during the study.
    • Low-risk PTC is defined as:
  • Maximum tumor diameter ≤1 cm;
  • Solitary lesion;
  • No local or distant metastasis;
  • No tumor invasion into extrathyroidal tissues;
  • No vascular invasion;
  • Non-invasive pathological subtype for the primary lesion (invasive subtypes include tall cell, columnar cell, diffuse sclerosing, solid/trabecular, and oncocytic vari ants);
  • No history of head and neck radiotherapy during adolescence;
  • No family history of thyroid cancer;
  • 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:
  • Maximum tumor diameter \>1 cm;
  • Multifocal thyroid cancer;
  • Local or distant metastasis;
  • Primary lesion with extrathyroidal extension;
  • Vascular invasion;
  • Primary lesion with an invasive pathological subtype;
  • History of head and neck radiotherapy during adolescence;
  • Family history of thyroid cancer;
  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.