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
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 4a 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. The histopathological is obtained as the "gold standerd" after surgical treatment.
Study Type
OBSERVATIONAL
Enrollment
400
To evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nudules with abnormal ultrasound features.
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
NOT_YET_RECRUITINGThe First Peple's Hospital of Changzhou
Changzhou, Jiangsu, China
NOT_YET_RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, China
To evaluation of Thyroscan's performance in diagnosing thyroid nodules
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.
Time frame: June,2022
To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.
Time frame: June,2022
To explore the inter-observer heterogeneity when reviewing fine needle aspiration biopsy(FNAB) by two senior cytopathologists.
Time frame: June,2022
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Zhejiang Provincial People's Hospital
Hangzhou, China
NOT_YET_RECRUITINGShanghai Jiaotong University School of Medicine
Shanghai, China
NOT_YET_RECRUITINGShenzhen People's Hospital
Shenzhen, China
NOT_YET_RECRUITINGTianjin Medical University Center Hospital
Tianjin, China
RECRUITING