Prospective, Blinded, Multi-center Clincal Study of NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 9
- 主要终点
- To evaluation of Thyroscan's performance in diagnosing thyroid nodules
研究概览
简要总结
The purpose of this study is to evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nodules with suspecious ultrasound features
详细描述
The prevalence of thyroid nodules by high-resolution ultrasound can be as high as 20%, though most of them are benign lesions, only about 5%-15% are malignant lesions. Based on 1.4 billion population in China, there are approximately 280 million thyroid nodule carriers, of which approximately 14-42 million are potential patients with thyroid cancer. Now thyroid cancer is the fastest growing cancer and the 4th most common cancer in women in China. Therefore, the key point in the evaluation of thyroid nodules is the differential diagnosis of benign and malignant nodules. At present, the commonly used imaging and cytological diagnostic techniques for thyroid nodules include ultrasound and ultrasound-guided fine needle aspiration biopsy (FNAB), as well as emerging molecular diagnostic techniques.
The purpose of this study is to evaluate the accuracy of Thyroscan in the diagnosis of benign and malignant thyroid nodules with suspecious ultrasound features. For patients who have signed an informed consent, the subjects undergo fine needle aspiration of thyroid nodules classified as C-TIRADS catagories 3 or 4 under the guidance of ultrasound or palpation before receiving surgical treatment. One needle is used to prepare cytological smear, and one needle is preserved and sent to Thyroscan detection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients sign the informed consent form for participating in the reasearch study.
- •Patient's age is 18 years or older.
- •Ultrasound showed at least one thyroid nodule, and it was classified as C-TIRADS Category 3/
- •The surgeon has confirmed surgical indication and the subject is willing to undergo the planned surgical intervention at the participating medical institution; or cytology results are benign, and the nodule(s) have remained clinically stable-defined as absence of new high-risk ultrasound features and no significant change in size on serial imaging.
- •Surgical indications include but are not limited to one of the following conditions: 1) Thyroid nodules are compressed or affect aesthetics; 2) The patient's subjective wishes require surgical removal of the nodules; 3) FNA samples with indeterminate cytology are classified as Bethesda III and IV, requiring diagnostic surgery; 4) After the investigator's assessment, there are other surgical indications.
- •Preoperative FNAB to obtain sufficient cells.
排除标准
- •The subject has a history of thyroid tumor.
- •The subject is not suitable for fine-needle aspiration biopsy and surgical treatment due to other conditions such as comorbid diseases.
- •Subjects who intend to receive the radiofrequency ablation therapy.
- •Other conditions determined by the researcher that do not meet the criteria of enrollment.
研究组 & 干预措施
Ultrasound findings of thyroid nodules classified as type 3 and 4 of C-TIRADS
干预措施: Thyroscan (Diagnostic Test)
结局指标
主要结局
To evaluation of Thyroscan's performance in diagnosing thyroid nodules
时间窗: June,2022
To explore the sensitivity, specificity, positive predictive value, negative predictive value, consistency and Kappa value of Thyroscan in the diagnosis of thyroid nodules with ultrasound features classified as C-TIRADS category 3/4a.
To evaluation of Thyroscan's performance in diagnosing thyroid nodules
时间窗: At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
To explore the sensitivity, specificity, positive predictive value, negative predictive value, consistency and Kappa value of Thyroscan in the diagnosis of thyroid nodules with ultrasound features classified as C-TIRADS category 3/4.
次要结局
- To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.(June,2022)
- To explore the inter-observer heterogeneity when reviewing fine needle aspiration biopsy(FNAB) by two senior cytopathologists.(June,2022)
- To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.(At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.)