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Thyroid Cancer, PapillaryNCT06725576

Ultrasound-Guided Microwave Ablation Vs. Surgery for Low-Risk PapilaryThyroid Carcinoma

An observational study of Thyroid Cancer, Papillary, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to investigate the efficacy and prognosis of ultrasound-guided and gene-based microwave ablation (MWA) versus surgical treatment in patients with low-risk papillary thyroid carcinoma (PTC). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Thyroid Cancer, Papillary
What is being tested?
Ablation
Type of treatment
Surgery or procedure
How many people
201 participants
Where
1 siteChina
Study dates
1 Jan 2022to 4 Mar 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population includes patients diagnosed with papillary thyroid carcinoma (PTC) at Sun Yat-Sen Memorial Hospital from January 2022 to November 2024. A total of 201 patients were prospectively enrolled in this study.

The inclusion criteria of this study were as followed:

  1. PTC confirmed by fine-needle aspiration (FNA);
  2. Confirmed low-risk mutation types by next-generation sequencing (NGS) before surgery;
  3. No severe functional diseases, such as heart failure, severe respiratory diseases, or renal failure;
  4. Availability of complete follow-up data.

The exclusion criteria were as followed:

  1. No local or distant metastasis assessed by imaging evaluations, including ultrasound or computed tomography (CT);
  2. Lacking of preoperative genetic testing or inability to assess genetic test results;
  3. Inability to complete follow-up or lost to follow-up during the study.

Low-risk PTC is defined as:

  1. Maximum tumor diameter ≤1 cm;
  2. Solitary lesion;
  3. No local or distant metastasis;
  4. No tumor invasion into extrathyroidal tissues;
  5. No vascular invasion;
  6. Non-invasive pathological subtype for the primary lesion (invasive subtypes include tall cell, columnar cell, diffuse sclerosing, solid/trabecular, and oncocytic vari ants);
  7. No history of head and neck radiotherapy during adolescence;
  8. No family history of thyroid cancer;
  9. Genetic testing showing BRAF V600E mutation (without concurrent TERT mutation), RAS family gene mutations, (HRAS, NRAS, KRAS), or other low-risk mutations, such as isolated RET/PTC) rearrangements.

Intermediate-high risk PTC is defined as:

  1. Maximum tumor diameter >1 cm;
  2. Multifocal thyroid cancer;
  3. Local or distant metastasis;
  4. Primary lesion with extrathyroidal extension;
  5. Vascular invasion;
  6. Primary lesion with an invasive pathological subtype;
  7. History of head and neck radiotherapy during adolescence;
  8. Family history of thyroid cancer;
  9. Genetic testing revealing high-risk mutation combinations, such as BRAF V600E or RAS mutations with concurrent TERT or TP53 mutations, or RAS mutations combined with EIF1AX mutations.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Miaoyun Long, MD contact

86-34070602

longmy@mail.sysu.edu.cn

Yuxin Shen, MBBS contact

86-15083138712

shenyx53@mail2.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510030

    Miaoyun Long, MD, 86-34070602, longmy@mail.sysu.edu.cn

    Yuxin Shen, MBBS, 86-15083138712, shenyx53@mail2.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Ultrasound and Gene-Guided Microwave Ablation Versus Surgery for Low-Risk Papillary Thyroid Carcinoma: a Prospective Observational Cohort Study.

This study aims to investigate the efficacy and prognosis of ultrasound-guided and gene-based microwave ablation (MWA) versus surgical treatment in patients with low-risk papillary thyroid carcinoma (PTC). By analyzing genetic testing results, the study explores the impact of genetic mutations on treatment selection for low-risk patients, providing more precise molecular biological evidence for treatment choices and prognosis evaluation of thyroid cancer. This prospective study collects clinical data from patients diagnosed with PTC at Sun Yat-sen Memorial Hospital of Sun Yat-sen University between January 2022 and November 2024, who underwent genetic testing prior to treatment, and assesses efficacy and complications through long-term follow-up.

Read the detailed description

Objective: This study evaluates and compares the efficacy and prognosis of ultrasound and gene-based microwave ablation (MWA) and surgical treatment in patients with low-risk papillary thyroid carcinoma (PTC), emphasizing the influence of genetic mutations on low-risk patients' selection.

Background: MWA, a minimally invasive technique, is increasingly recognized in the management of PTC. While traditional criteria for ablation focus on tumor size, number, and location, the impact of genetic mutations on treatment efficacy remains underexplored.

Methods: A total of 201 patients with low-risk PTC without metastasis were prospectively enrolled. All patients underwent ultrasound and next-generation sequencing to confirm low-risk status. Patients chose either ablation or surgery and were monitored until November 2024. Efficacy and complications were assessed using thyroid ultrasound and contrast-enhanced ultrasound.

Being tested
Ablation
Keywords
Papillary Thyroid Carcinoma, Ablation Therapy, Personalized treatment, Thyroid cancer gene mutations
Medical subject headings
Thyroid Cancer, Papillary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AblationProcedure or surgery

    Thyroid ablation performed under ultrasound guidance to treat low-risk papillary thyroid carcinoma.

Study groups in NCT06725576
Study groupRoleWhat they receive
Ablation GroupPatients in this group received ablation therapy for low-risk papillary thyroid carcinoma. The ablation method used was microwave ablation (MWA), with ablation performed under ultrasound guidance. Patients were informed of the potential risks and benefits of ablation, and follow-ups were conducted at regular intervals using thyroid ultrasound and contrast-enhanced ultrasound to evaluate treatment efficacy and disease progression.
Receives: Procedure: Ablation
Surgery GroupPatients in this group underwent surgical treatment for low-risk papillary thyroid carcinoma. The surgery performed was partial or total thyroidectomy, based on the patient's condition and preferences. Patients were informed of the risks, including potential complications such as hypothyroidism, recurrent laryngeal nerve injury, and hypoparathyroidism. Follow-ups were conducted using thyroid ultrasound and clinical assessments to monitor for recurrence and evaluate postoperative recovery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease progression

    The primary endpoint was disease progression, defined as: (1) local recurrence or cervical lymph node metastasis confirmed by FNA; (2) Distant organ metastasis; (3) Death due to tumor progression.

    Measured: through study completion, an average of 1 year

Secondary outcomes (7)

  1. Complications

    Such as permanent or transient hypoparathyroidism, recurrent laryngeal nerve injury, postoperative hypertension, infection, fever, pain, and nausea or vomiting. Permanent hypoparathyroidism was defined as the need for calcium or vitamin D supplementation beyond six months, while transient hypoparathyroidism indicated recovery within six months. Permanent recurrent laryngeal nerve injury was defined as persistent voice changes beyond six months, while transient injury indicated recovery within six months.

    Measured: through study completion, an average of 1 year

  2. Treatment costs

    Including preoperative tests and treatment costs

    Measured: through study completion, an average of 1 year

  3. Time of hospital stay

    The total duration of hospital stay from admission to discharge.

    Measured: from admission to discharge, up to 1 week.

  4. Operative time

    Time from the start of surgery to the completion of surgery.

    Measured: immediately after the intervention

  5. Ablation efficacy

    Defined as complete or incomplete ablation based on Contrast-enhanced ultrasound (CEUS).

    Measured: Follow-up examination one month after treatment.

  6. Changes in ablation zone volume

    Measured before and after treatment

    Measured: through study completion, an average of 1 year

  7. Thyroid function

    The proportion of patients with thyroid dysfunction after treatment.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2024
  2. Study start1 Jan 2022
  3. Primary completion4 Mar 2025 (estimated)
  4. Study completion4 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
201 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06725576
Sponsor's protocol ID
SYSKY-2024-169-01
Other IDs
No. 82404087, No.2023A1515011214, No. 2023A03J0722, No. 2024A03J1
Status last verified
Dec 2024
First submitted
5 Dec 2024
Last updated
31 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Cancer, Papillary, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Miaoyun Long, MD (86-34070602, longmy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease progression (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06725576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.

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