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

NCT06725576 | Recruiting

• 5 other identifiers: SYSKY-2024-169-01No. 82404087No.2023A1515011214No. 2023A03J0722No. 2024A03J1
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Thyroid Cancer, Papillary

Keywords

Papillary Thyroid Carcinoma; Ablation Therapy; Personalized treatment; Thyroid cancer gene mutations

Outcome Measures

Primary Outcomes (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.

  through study completion, an average of 1 year

Secondary Outcomes (7)

• Complications

  through study completion, an average of 1 year

• Treatment costs

  through study completion, an average of 1 year

• Time of hospital stay

  from admission to discharge, up to 1 week.

• Operative time

  immediately after the intervention

• Ablation efficacy

  Follow-up examination one month after treatment.

Study Arms (2)

Ablation Group

Patients 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.

Procedure: Ablation

Surgery Group

Patients 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.

Interventions

Ablation PROCEDURE

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

Ablation Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• No local or distant metastasis assessed by imaging evaluations, including ultrasound or computed tomography (CT);
• Lacking of preoperative genetic testing or inability to assess genetic test results;
• Inability to complete follow-up or lost to follow-up during the study.
• Low-risk PTC is defined as:
• Maximum tumor diameter ≤1 cm;
• Solitary lesion;
• No local or distant metastasis;
• No tumor invasion into extrathyroidal tissues;
• No vascular invasion;
• Non-invasive pathological subtype for the primary lesion (invasive subtypes include tall cell, columnar cell, diffuse sclerosing, solid/trabecular, and oncocytic vari ants);
• No history of head and neck radiotherapy during adolescence;
• No family history of thyroid cancer;
• 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:
• Maximum tumor diameter \>1 cm;

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• National Natural Science Foundation of China: collaborator
• Guangzhou Science and Technology Innovation Commission,China: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 510030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Next-generation sequencing (NGS) data of thyroid cancer

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Miaoyun Long, MD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Miaoyun Long, MD

CONTACT

86-34070602; longmy@mail.sysu.edu.cn

Yuxin Shen, MBBS

CONTACT

86-15083138712; shenyx53@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: January 1, 2022
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

CN (1)