NCT05025046Completed
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
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 250 (actual)
- First submitted
- 25 Aug 2021
- Start date
- 1 Sept 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Rigen Biotech
- Diseases
- Thyroid cancer
- NCT number
- NCT05025046
What you commit to
- Study type: Observational
- Participants enrolled: 250
- From 1 Sept 2021 to the primary completion date, 31 Dec 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who intend to receive the radiofrequency ablation therapy.
Other illness
- 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.
- Other conditions determined by the researcher that do not meet the criteria of enrollment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Peple's Hospital of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tianjin Medical University Center Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.