NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 1442 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ultrasound findings of thyroid nodules classified as type 3 and 4a of TIRADS
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Diagnostic Test: Thyroscan
To evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nudules with abnormal ultrasound features.
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Outcome Measures
Primary Outcome Measures
- To evaluation of Thyroscan's performance in diagnosing thyroid nodules [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.
Secondary Outcome Measures
- 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]
Other Outcome Measures
- To explore the cost-effectiveness analysis of Thyroscan. [June,2022]
- To reveals the correlation between molecular landscape and clinical-pathological characteristics of thyroid nodules. [June,2022]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients sign the informed consent form for participating in the reasearch study.
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Patient's age is 18 years or older.
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Ultrasound showed at least one thyroid nodule, and it was classified as C-TIRADS Category 3/4a.
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The surgeon has evaluated the indications for surgery, and the subject is willing to receive surgical intervention in the medical institution.
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Surgical indications include but are not limited to one of the following conditions:
- 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.
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Preoperative FNAB to obtain sufficient cells to meet FNA samples with indeterminate cytology are classified as Bethesda III and IV.
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The final pathological diagnosis is obtained after surgury.
Exclusion Criteria:
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The subject has a history of thyroid tumor.
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The subject has swollen lymph nodes in the central area or/and lateral neck area.
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The subject is not suitable for fine-needle aspiration biopsy and surgical treatment due to other conditions such as comorbid diseases.
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FNAB interprets the thyroid nodule as Bethesda V and VI categories.
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Subjects who intend to receive the radiofrequency ablation therapy.
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Other conditions determined by the researcher that do not meet the criteria of enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan City People's Hospital | Zhongshan | Guangdong | China | 528400 |
| 2 | The First Peple's Hospital of Changzhou | Changzhou | Jiangsu | China | 213000 |
| 3 | Guangdong Provincial People's Hospital | Guangzhou | China | 510000 | |
| 4 | Zhejiang Provincial People's Hospital | Hangzhou | China | 310000 | |
| 5 | Shanghai Jiaotong University School of Medicine | Shanghai | China | 200000 | |
| 6 | Shenzhen People's Hospital | Shenzhen | China | 518000 | |
| 7 | Tianjin Medical University Center Hospital | Tianjin | China | 300000 |
Sponsors and Collaborators
- Rigen Biotech
- Tianjin Medical University Cancer Institute and Hospital
- Guangdong Provincial People's Hospital
- RenJi Hospital
- Zhejiang Provincial People's Hospital
- The First People's Hospital of Changzhou
- Shenzhen People's Hospital
- Zhongshan People's Hospital, Guangdong, China
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RigenBio