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Spots Global Cancer Trial Database for NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules

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Trial Identification

Brief Title: NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules

Official Title: Prospective, Blinded, Multi-center Clincal Study of NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules

Study ID: NCT05025046

Interventions

Thyroscan

Study Description

Brief Summary: 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

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Zhongshan City People's Hospital, Zhongshan, Guangdong, China

The First Peple's Hospital of Changzhou, Changzhou, Jiangsu, China

Guangdong Provincial People's Hospital, Guangzhou, , China

Zhejiang Provincial People's Hospital, Hangzhou, , China

Shanghai Jiaotong University School of Medicine, Shanghai, , China

Shenzhen People's Hospital, Shenzhen, , China

Tianjin Medical University Center Hospital, Tianjin, , China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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