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Genetic test may spare patients from unnecessary thyroid surgery

NCT ID NCT05025046

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

250 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

thyroid cancer Thyroid Neoplasms Thyroid Nodule

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Shanghai Jiaotong University School of Medicine

    Shanghai, 200000, China

  • The First Peple's Hospital of Changzhou

    Changzhou, Jiangsu, 213000, China

  • Tianjin Medical University Center Hospital

    Tianjin, 300000, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.