Safety and Quality of Life of Three Treatment Strategies for Low-Risk Papillary Thyroid Microcarcinoma

Официальное название

A Prospective Registry Study Evaluating the Safety and Quality of Life of Three Treatment Strategies - Surgical Resection, Thermal Ablation, and Active Surveillance - for Patients With Low-Risk Papillary Thyroid Microcarcinoma

Обзор

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.

Первичные конечные точки

• Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 10 years [Срок оценки: 10 years]

Вторичные конечные точки (6)

• Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 5 years [Срок оценки: 5 years]
• Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 5 years (Active Surveillance group) [Срок оценки: 5 years]
• Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 10 years (Active Surveillance group) [Срок оценки: 10 years]
• Overall survival rate at 10 years [Срок оценки: 10 years]
• Conversion rate from active surveillance to surgery [Срок оценки: Up to 10 years]
• Quality of life scores at 1, 3, 5, and 10 years [Срок оценки: 1, 3, 5, and 10 years]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Xijing hospital — Сиань

Идентификаторы

NCT: NCT07249125 · KY20252532-C-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗