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

NCT07249125 | Not Yet Recruiting

• 1 other identifier: KY20252532-C-1
• Study Type: observational
• Target: 1,630
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Papillary Thyroid Microcarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  5 years

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

  5 years

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

  10 years

• Overall survival rate at 10 years

  10 years

• Conversion rate from active surveillance to surgery

  Up to 10 years

Other Outcomes (1)

• Incidence of adverse events (AEs) and serious adverse events (SAEs)

  Throughout the 10-year follow-up period

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Papillary Thyroid Microcarcinoma

Central Study Contacts

Zhe Wang, Dr

CONTACT

029-84775271; wangzhe9263@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2038
• Study Completion (Estimated): June 1, 2039
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after main publication; available for at least 5 years thereafter.
• Access Criteria: Researchers may request access through the corresponding author by submitting a proposal and a data use agreement.

Locations

CN (1)