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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05025046
• Other study ID #: RigenBio
• Status: Recruiting
• Start date: September 2021
• Est. completion date: June 2022

Study information

• Verified date: September 2021
• Source: Rigen Biotech
• Contact: Liang Hanzi
• Phone: +8613895604662
• Email: liang.hanzi[@]rigen-bio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 3/4a.

4. The surgeon has evaluated the indications for surgery, and the subject is willing to receive surgical intervention in the medical institution.

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 to meet FNA samples with indeterminate cytology are classified as Bethesda III and IV.

7. The final pathological diagnosis is obtained after surgury.

Exclusion Criteria:

1. The subject has a history of thyroid tumor.

2. The subject has swollen lymph nodes in the central area or/and lateral neck area.

3. The subject is not suitable for fine-needle aspiration biopsy and surgical treatment due to other conditions such as comorbid diseases.

4. FNAB interprets the thyroid nodule as Bethesda V and VI categories.

5. Subjects who intend to receive the radiofrequency ablation therapy.

6. Other conditions determined by the researcher that do not meet the criteria of enrollment.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

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

Locations

Country	Name	City	State
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	Zhongshan City People's Hospital	Zhongshan	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
Rigen Biotech	Guangdong Provincial People's Hospital, RenJi Hospital, Shenzhen People's Hospital, The First People's Hospital of Changzhou, Tianjin Medical University Cancer Institute and Hospital, Zhejiang Provincial People's Hospital, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To explore the cost-effectiveness analysis of Thyroscan.		June,2022
Other	To reveals the correlation between molecular landscape and clinical-pathological characteristics of thyroid nodules.		June,2022
Primary	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.	June,2022
Secondary	To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.		June,2022
Secondary	To explore the inter-observer heterogeneity when reviewing fine needle aspiration biopsy(FNAB) by two senior cytopathologists.		June,2022