Genetic test may spare patients from unnecessary thyroid surgery
NCT ID NCT05025046
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This study evaluates Thyroscan, a genomic test that analyzes genetic material from thyroid nodule samples, to see if it can accurately distinguish benign from malignant nodules. The trial involves 250 adults with suspicious thyroid nodules who are scheduled for surgery or have stable benign cytology. The goal is to measure the test's sensitivity, specificity, and overall diagnostic accuracy compared to standard cytopathology.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Thyroscan, a genomic classifier test that analyzes genetic material from a thyroid nodule sample to help determine if it is benign or malignant.
- What this could lead to
- If accurate, Thyroscan could help many people with suspicious thyroid nodules avoid unnecessary surgery by reliably identifying benign ones.
- What could go wrong
- The test is still being studied and may not be accurate enough to replace current methods. Its performance in real-world settings is not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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250 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients that ultrasound scan identified at least one thyroid nodule, which was classified as category 3 and 4 according to the C-TIRADS guideline.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shanghai Jiaotong University School of Medicine
Shanghai, 200000, China
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The First Peple's Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
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Tianjin Medical University Center Hospital
Tianjin, 300000, China
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Zhejiang Provincial People's Hospital
Hangzhou, 310000, China
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Other studies related to the condition(s) this trial covers.
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