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

Rigen Biotech250 enrolled

Overview

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 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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Thyroid Nodule Thyroid Cancer

Interventions

ThyroscanDIAGNOSTIC_TEST

To evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nudules with abnormal ultrasound features.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients sign the informed consent form for participating in the reasearch study. 2. Patient's age is 18 years or older. 3. Ultrasound showed at least one thyroid nodule, and it was classified as C-TIRADS Category 3/4. 4. 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. 5. 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. 6. Preoperative FNAB to obtain sufficient cells. Exclusion Criteria: 1. The subject has a history of thyroid tumor. 2. The subject is not suitable for fine-needle aspiration biopsy and surgical treatment due to other conditions such as comorbid diseases. 3. Subjects who intend to receive the radiofrequency ablation therapy. 4. Other conditions determined by the researcher that do not meet the criteria of enrollment.

Locations (4)

The First Peple's Hospital of Changzhou

Changzhou, Jiangsu, China

Zhejiang Provincial People's Hospital

Hangzhou, China

Shanghai Jiaotong University School of Medicine

Shanghai, China

Tianjin Medical University Center Hospital

Tianjin, China

Outcomes

Primary Outcomes

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 3/4.

Time frame: At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.

Secondary Outcomes

To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.

Time frame: At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.

Data from ClinicalTrials.gov

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