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

August 12, 2026 updated by: Rigen Biotech

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

Completed

Conditions

Intervention / Treatment

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 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 (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hangzhou, China, 310000
        • Zhejiang Provincial People's Hospital
      • Shanghai, China, 200000
        • Shanghai Jiaotong University School of Medicine
      • Tianjin, China, 300000
        • Tianjin Medical University Center Hospital
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • The First Peple's Hospital of Changzhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients that ultrasound scan identified at least one thyroid nodule, which was classified as category 3 and 4 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 3/4.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ultrasound findings of thyroid nodules classified as type 3 and 4 of C-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
Time Frame: At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
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.
At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
To reveals the correlation between molecular landscape and clinical-pathological characteristics of thyroid nodules.
Time Frame: At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigen Biotech

Collaborators

RenJi Hospital
Tianjin Medical University Cancer Institute and Hospital
Zhejiang Provincial People's Hospital
The First People's Hospital of Changzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

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)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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