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

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

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

Study Overview

• Status: Recruiting
• Conditions: Thyroid Cancer; Thyroid Nodule
• Intervention / Treatment: Diagnostic test: Thyroscan

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Liang Hanzi; Phone Number: +8613895604662; Email: liang.hanzi@rigen-bio.com

Study Locations

• China
  • Guangzhou, China, 510000
    • Not yet recruiting
    • Guangdong Provincial People's Hospital
    • Contact: Guan Haixia
  • Hangzhou, China, 310000
    • Not yet recruiting
    • Zhejiang provincial people's hospital
    • Contact: Zheng Chuanmin
  • Shanghai, China, 200000
    • Not yet recruiting
    • Shanghai Jiaotong University School of Medicine
    • Contact: Wang Zhuoying
  • Shenzhen, China, 518000
    • Not yet recruiting
    • Shenzhen People's Hospital
  • Tianjin, China, 300000
    • Recruiting
    • Tianjin Medical University Center Hospital
    • Contact: Zheng Xiangqian
  • Guangdong
    • Zhongshan, Guangdong, China, 528400
      • Not yet recruiting
      • Zhongshan City People's Hospital
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • Not yet recruiting
      • The First Peple's Hospital of Changzhou
      • Contact: Li Qing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that ultrasound scan identified at least one thyroid nodule, which was classified as category 3 and 4a according to the C-TIRADS guideline.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultrasound findings of thyroid nodules classified as type 3 and 4a of TIRADS	Diagnostic test: Thyroscan; To evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nudules with abnormal ultrasound features.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: RigenBio

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No