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

NCT05025046 | Completed

• 1 other identifier: RigenBio
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 4

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

Conditions

Thyroid Nodule; Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.

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

Other Outcomes (1)

• To reveals the correlation between molecular landscape and clinical-pathological characteristics of thyroid nodules.

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

Study Arms (1)

Ultrasound findings of thyroid nodules classified as type 3 and 4 of C-TIRADS

Diagnostic Test: Thyroscan

Interventions

Thyroscan DIAGNOSTIC_TEST

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

Ultrasound findings of thyroid nodules classified as type 3 and 4 of C-TIRADS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients sign the informed consent form for participating in the reasearch study.
• Patient's age is 18 years or older.
• Ultrasound showed at least one thyroid nodule, and it was classified as C-TIRADS Category 3/4.
• 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.
• 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.
• Preoperative FNAB to obtain sufficient cells.

You may not qualify if:

• The subject has a history of thyroid tumor.
• The subject is not suitable for fine-needle aspiration biopsy and surgical treatment due to other conditions such as comorbid diseases.
• Subjects who intend to receive the radiofrequency ablation therapy.
• Other conditions determined by the researcher that do not meet the criteria of enrollment.

Sponsors & Collaborators

• Rigen Biotech: lead
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• RenJi Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• The First People's Hospital of Changzhou: collaborator

Study Sites (4)

The First Peple's Hospital of Changzhou

Changzhou, Jiangsu, 213000, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, 310000, China

Location

Shanghai Jiaotong University School of Medicine

Shanghai, 200000, China

Location

Tianjin Medical University Center Hospital

Tianjin, 300000, China

Location

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 27, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

CN (4)