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临床试验/NCT07054229
NCT07054229招募中不适用

Efficacy and Prognosis of Microwave Ablation Treatment for Papillary Thyroid Microcarcinoma Assessed by Contrast-Enhanced Ultrasound Combined With Genetic and Molecular Diagnostics: A Prospective Observational Study

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
480
试验地点
1
主要终点
Efficacy and prognosis of microwave ablation therapy for papillary thyroid microcarcinoma

研究概览

简要总结

In 2016, there were 203,000 new cases of thyroid cancer in China, ranking 7th among all malignant tumours and 4th among women, and showing a rapid growth trend. Papillary thyroid cancer (PTMC) with a diameter of ≤10 mm is the most common type of thyroid cancer, accounting for about 50% to 60% of the total number of cases. Low-risk PTMC is the most common type of thyroid cancer, with low invasiveness and good prognosis. Surgery is the treatment of choice for low-risk PTMC, but it significantly affects the quality of life of patients by affecting the function of the thyroid gland and requiring long-term medication after surgery, as well as having a high incidence of intra- and postoperative complications; there are certain impacts and limitations in the actual treatment. Microwave ablation (MWA) is a therapeutic modality emerging in recent years, which has the characteristics of easy operation, precise positioning, safety and effectiveness, small postoperative damage, fast recovery, fewer complications, and does not affect the aesthetics of the patient, which not only avoids surgical trauma and reduces the anxiety of the patient, but also better preserves the function of the thyroid gland, and its clinical application is becoming more and more widespread. In recent years, the application of microwave ablation in the treatment of PTMC has received more and more attention. Ultrasound, as a first-line examination tool, is accepted by the majority of patients because of its advantages of safety, speed, efficiency, low price and painlessness. Contrast-enhanced ultrasound (CEUS) is a new examination technique developed in recent years, which can provide richer and clearer diagnostic information than conventional ultrasound and colour Doppler ultrasound. Ultrasound contrast agents (e.g. Sonovue, Sonazoid), Sonovue with sulphur hexafluoride microbubbles as the main ingredient and Sonazoid with perfluorobutane microbubbles as the main ingredient, are non-toxic, non-radioactive, do not require allergy testing, and do not have the advantages of liver or kidney toxicity, etc., and are increasingly recognised by the public. Ultrasonography is now widely used in clinical practice as the primary modality for assessing efficacy after thyroid ablation therapy. Molecular diagnosis is one of the most important tools for preoperative diagnosis and invasiveness assessment of thyroid cancer. Common thyroid cancer gene variants include point mutations such as BRAF V600E, RAS, TP53, PIK3CA, and gene integration variants such as CCDC6-RET and ETV6-NTRK3. This project intends to assess the efficacy and prognosis of microwave ablation therapy for micropapillary thyroid cancer by ultrasonography combined with genetic molecular diagnosis, which in turn will assist in clinical treatment decisions.

详细描述

1.1 Background to the study 1.1.1 Overview of thyroid cancer

Thyroid cancer is the most prevalent malignancy of the endocrine system. Data from the National Cancer Centre show that:

203,000 new cases of thyroid cancer in China in 2016, ranking 7th among all malignant tumours and 4th among women, and showing a rapid growth trend. The most common pathological type of thyroid cancer is papillary thyroid carcinoma (PTC), which accounts for about 85%-90% of the total number of cases, followed by follicular thyroid carcinoma (FTC), medullary thyroid carcinoma (MTC), poorly differentiated thyroid carcinoma (PDTC) and undifferentiated carcinoma (ATC).

1.1.2 Overview of PTMC and its surgical treatment Papillary thyroid carcinoma (PTMC) refers to papillary carcinoma with a diameter of ≤10 mm, whose biological behaviour is relatively mild and disease-specific.

behaviour is relatively mild, and the disease-specific mortality rate is less than 1%. Surgery is currently the treatment of choice for PTMC, and studies have shown that the overall survival rates of PTMC at 10 and 15 years after surgery are 94.6% and 90.7%, respectively.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-70 years, gender not specified;
  • Patients with low-risk PTMC receiving initial treatment (meeting all the following conditions: single lesion with a maximum diameter ≤1cm; no cervical lymph node metastasis; no distant metastasis; no extrathyroidal extension; no family history of thyroid cancer; no history of head and neck radiation during childhood);
  • Patients who have undergone fine-needle aspiration cytology examination of thyroid nodules and 88-gene panel testing for thyroid cancer before surgery;
  • Patients voluntarily choose to undergo microwave ablation therapy or surgical resection.

排除标准

  • Tumor located in the isthmus of the thyroid;
  • Pathological high-risk subtypes (tall cell subtype, columnar cell subtype, diffuse sclerosing subtype, solid/insular subtype, oncocytic subtype);
  • Progressive enlargement of the cancer lesion in the short term (increase of more than 3mm within 6 months);
  • Pregnant women, lactating women;
  • Patients with severe coagulation disorders;
  • Patients with contralateral vocal cord dysfunction;
  • Patients with contraindications to ultrasound contrast agents;
  • Other conditions deemed ineligible for enrollment by the investigator.

研究组 & 干预措施

The thyroid nodule was confirmed to be papillary thyroid microcarcinoma by fine-needle aspiration bi

  1. Aged 18-70 years, gender not specified;
  2. Patients with low-risk PTMC receiving initial treatment (meeting all the following criteria: single lesion with a maximum diameter ≤1cm; no cervical lymph node metastasis; no distant metastasis; no extrathyroidal extension; no family history of thyroid cancer; no history of head and neck radiation during childhood);
  3. Patients who have undergone fine-needle aspiration cytology examination of thyroid nodules and 88-gene testing for thyroid cancer before surgery;
  4. Patients voluntarily choose to undergo microwave ablation therapy or surgical resection.

干预措施: Contrast enhanced Ultrasound (Drug)

The thyroid nodule was confirmed to be papillary thyroid microcarcinoma by fine-needle aspiration bi

  1. Aged 18-70 years, gender not specified;
  2. Patients with low-risk PTMC receiving initial treatment (meeting all the following criteria: single lesion with a maximum diameter ≤1cm; no cervical lymph node metastasis; no distant metastasis; no extrathyroidal extension; no family history of thyroid cancer; no history of head and neck radiation during childhood);
  3. Patients who have undergone fine-needle aspiration cytology examination of thyroid nodules and 88-gene testing for thyroid cancer before surgery;
  4. Patients voluntarily choose to undergo microwave ablation therapy or surgical resection.

干预措施: 88-gene panel for thyroid cancer (Genetic)

结局指标

主要结局

Efficacy and prognosis of microwave ablation therapy for papillary thyroid microcarcinoma

时间窗: 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months postoperatively

Record the absorption status of the ablated lesion: volume observed by ultrasound imaging after ablation, and assess for the presence or absence of lymph node metastasis.Then, we will compile the postoperative follow-up ultrasound data-including volume measurements and lymph node metastasis status-into an Excel spreadsheet.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiyun Ou

Dr.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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