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NCT Number: NCT07249125

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

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.

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Key information

Conditions

Papillary Thyroid Microcarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 10 years

    Time frame: 10 years

    The proportion of participants who show radiologic evidence of lymph node metastasis confirmed by fine-needle aspiration during 10 years of follow-up.

Secondary outcomes

  1. Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 5 years

    Time frame: 5 years

    The proportion of participants with imaging findings suggestive of lymph node metastasis confirmed by fine-needle aspiration at 5 years.

  2. Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 5 years (Active Surveillance group)

    Time frame: 5 years

    Among participants in the active surveillance group, the proportion of thyroid nodules showing an ultrasound-measured increase of at least 3 mm in maximal diameter within 5 years of follow-up.

  3. Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 10 years (Active Surveillance group)

    Time frame: 10 years

    Among active surveillance participants, the proportion of thyroid nodules showing an ultrasound-measured increase of 3 mm or more in maximal diameter within 10 years.

  4. Overall survival rate at 10 years

    Time frame: 10 years

    The proportion of participants who remain alive at 10 years from baseline, regardless of disease status or treatment modality.

  5. Conversion rate from active surveillance to surgery

    Time frame: Up to 10 years

    The proportion of participants initially managed with active surveillance who undergo surgical intervention during the study period.

  6. Quality of life scores at 1, 3, 5, and 10 years

    Time frame: 1, 3, 5, and 10 years

    Changes in patient-reported quality of life over time, evaluated using the Fear of Progression Questionnaire-Short Form (FoP-Q-SF) and the Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QoL).

Other outcomes

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Throughout the 10-year follow-up period

    Number and percentage of participants experiencing any study-related adverse events or serious adverse events, collected throughout the study and categorized by severity and relationship to treatment type.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhe Wang, Dr

CONTACT

[email protected]

029-84775271

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Acronym: PTMC-3S

Important dates

Study start
2025
Primary completion
2038
Study completion
2039
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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