Safety and Quality of Life of Three Treatment Strategies for Low-Risk Papillary Thyroid Microcarcinoma (PTMC-3S)

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Papillary Thyroid Microcarcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT07249125

KY20252532-C-1

Details and patient eligibility

About

This is a prospective observational patient registry study designed to evaluate the safety and quality of life associated with three treatment strategies for patients diagnosed with low-risk papillary thyroid microcarcinoma (PTMC): surgical resection, thermal ablation, and active surveillance.

The study aims to collect standardized, real-world clinical data from participating centers. Patients will receive one of the three treatment strategies according to clinical judgment and personal preference. The study team will prospectively follow participants to record safety events, disease progression, and patient-reported quality of life outcomes.

By comparing the outcomes among the three treatment groups, this registry seeks to provide evidence to support personalized and evidence-based decision-making for the management of low-risk PTMC.

Enrollment: 1,630 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A single papillary thyroid carcinoma (PTC) lesion with a maximum diameter ≤ 1 cm confirmed by imaging.
• No evidence of extrathyroidal extension on imaging studies.
• No clinical or radiologic evidence of cervical lymph node metastasis.
• No evidence of distant metastasis.
• Histopathological confirmation of papillary thyroid carcinoma.
• The patient has provided written informed consent and agrees to select one of the predefined management strategies (surgical resection, thermal ablation, or active surveillance).

Exclusion criteria

• Ultrasound-confirmed tumor with a maximum diameter > 1 cm.
• Imaging findings (ultrasound/CT/MRI) suggestive of extrathyroidal extension.
• Tumor located adjacent to critical structures (e.g., trachea, esophagus, or recurrent laryngeal nerve) with possible invasion risk.
• History of thyroidectomy, radiofrequency/microwave/laser ablation, or radioactive iodine therapy.
• Failure to provide written informed consent.

Trial design

1,630 participants in 3 patient groups

Surgical Resection

Description:

Participants undergo standard thyroid surgery (lobectomy or total thyroidectomy) for low-risk papillary thyroid microcarcinoma. Outcomes on safety, complications, and postoperative quality of life are collected prospectively.

Thermal Ablation

Description:

Participants receive minimally invasive thermal ablation, such as radiofrequency or microwave ablation, for papillary thyroid microcarcinoma. Data include procedural safety, ablation completeness, and patient-reported quality of life.

Active Surveillance

Description:

Participants choose active surveillance instead of immediate intervention. Regular follow-up with ultrasound and clinical assessment is conducted to monitor tumor progression, safety events, and quality of life over time.