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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Papillary Thyroid Microcarcinoma

• Study Type: Observational
• Enrollment (Estimated): 1630

Contacts and Locations

• Study Contact: Name: Zhe Wang, Dr; Phone Number: 029-84775271; Email: wangzhe9263@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital
      • Contact: Zhe Wang, Dr; Phone Number: 029-84775271; Email: wangzhe9263@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with low-risk papillary thyroid microcarcinoma (maximum diameter ≤1 cm), with no evidence of extrathyroidal extension, lymph node metastasis, or distant metastasis, who choose one of three management strategies: surgical resection, thermal ablation, or active surveillance.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Surgical Resection; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 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.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of lymph node metastasis confirmed by imaging and fine-needle aspiration within 5 years	The proportion of participants with imaging findings suggestive of lymph node metastasis confirmed by fine-needle aspiration at 5 years.	5 years
Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 5 years (Active Surveillance group)	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.	5 years
Proportion of nodules with ≥3 mm increase in maximal diameter on ultrasound within 10 years (Active Surveillance group)	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.	10 years
Overall survival rate at 10 years	The proportion of participants who remain alive at 10 years from baseline, regardless of disease status or treatment modality.	10 years
Conversion rate from active surveillance to surgery	The proportion of participants initially managed with active surveillance who undergo surgical intervention during the study period.	Up to 10 years
Quality of life scores at 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).	1, 3, 5, and 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs) and serious adverse events (SAEs)	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.	Throughout the 10-year follow-up period

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 31, 2038
• Study Completion (Estimated): June 1, 2039

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Papillary Thyroid Microcarcinoma
• Other Study ID Numbers: KY20252532-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) will be available upon reasonable request after publication of the main results. Data will be shared with qualified researchers with a methodologically sound proposal, subject to approval by the study steering committee.
• IPD Sharing Time Frame: Starting 6 months after main publication; available for at least 5 years thereafter.
• IPD Sharing Access Criteria: Researchers may request access through the corresponding author by submitting a proposal and a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No