Clinical trial · Observational
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
NCT05025046CI-TRIAL-00122083completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thyroscan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ultrasound findings of thyroid nodules classified as type 3 and 4 of C-TIRADS
- interventionNames
- Diagnostic Test: Thyroscan
Primary outcomes (1)
- measure
- To evaluation of Thyroscan's performance in diagnosing thyroid nodules
- timeFrame
- At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
- description
- 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.
Secondary outcomes (1)
- measure
- To compared with cytopathology and Thyroscan in diagnosing thyroid nodules.
- timeFrame
- At the time of postsurgical pathology report, or upon completion of the 12-month follow-up for non-surgical participants.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.