Active Surveillance for Low-risk Papillary Thyroid Carcinoma

• Conditions: Thyroid Cancer; Papillary Thyroid Carcinoma

• Registration Number: NCT06261190
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

This is a multi-center, non-randomized, prospective observational cohort study aimed at establishing a cohort of low-risk papillary thyroid cancer patients with a maximum tumor diameter of 1.5 cm or less, consisting of an active surveillance group and an immediate surgery group.

Detailed Description

The primary objective of this study is to evaluate the natural course of low-risk papillary thyroid cancer, specifically the progression rates of tumor size increase and the occurrence of local or distant metastasis. Ultimately, it is expected that establishing new criteria for active surveillance of low-risk papillary thyroid cancer in Korean patients will lead to a reduction in unnecessary surgical treatments, improving quality of life and decreasing national healthcare costs.

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-15
• Study Start: 2024-03-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2029-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 499

Inclusion Criteria

• subjects over 18 years old with a thyroid nodule of ≤ 1.5 cm in maximum diameter and a Bethesda category V or VI diagnosis on cytopathology
• subjects without high-risk features, including lymph node (LN) metastasis, distant metastasis, signs or symptoms of invasion to the recurrent laryngeal nerve or trachea, Poorly differentiated cancer or variant with a poor prognosis, such as the tall cell, diffuse sclerosing, columnar cell, or solid variants.

Exclusion Criteria

• subjects who are unable or unwilling to attend regular follow-ups..
• subjects with a diagnosis of benign, atypia of undetermined significance, suspicious for follicular neoplasm, or follicular neoplasm (Bethesda category II, III, or IV) based on Fine needle aspiration or, or benign, indeterminate by core needle biopsy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of disease progression between the active surveillance group and the immediate surgery group	At 5years, 10years after enrollment	Disease progression in the following criteria: (1) a size increase of ≥3 mm in maximum diameter or size increase of ≥2 mm in two diameters; (2) a cytopathological diagnosis of a new thyroid cancer lesion; (3) a cytopathological diagnosis of a cervical lymph node metastasis; or (4) clinical or radiological suspicion of a distant metastasis.

Secondary Outcome Measures

Name	Time	Method
Risk factors for disease progression in the active surveillance group	At 5years, 10years after enrollment	To evaluate the risk factors for progression to thyroid cancer based on demographic factors, serial ultrasound findings, blood markers, and molecular pathological characteristics at each follow-up visit.
Rate of conversion to surgery without disease progression in the active surveillance group	At 5years, 10years after enrollment	To estimate the proportion of patients in the active surveillance group who undergo surgery without clinical evidence of progression to thyroid cancer, evaluated at each follow-up visit.
Rate of Disease Progression Between the Immediate Surgery Group and the Surgery-After-Progression Group	At 5years, 10years after enrollment	The outcome will be measured as the proportion (%) of patients in each group who experience disease progression at each follow-up visit.; Disease progression is defined as meeting any of the following criteria: 1. an increase in tumor size of ≥3 mm in maximum diameter, or ≥2 mm in two perpendicular diameters; 2. a cytopathological diagnosis of a new thyroid cancer lesion; 3. a cytopathological diagnosis of cervical lymph node metastasis; 4. clinical or radiological suspicion of distant metastasis.
Factors influencing treatment decision-making	At 5years, 10years after enrollment	To evaluate the factors influencing the decision to pursue active surveillance, undergo surgery, or modify the treatment.
Decision Conflict Scale Score	For the first 2 years, every 6 months, then every 6-12 months depending on the condition.	The level of confidence in decision-making will be assessed at each follow-up visit using the Decision Conflict Scale. This questionnaire evaluates the level of agreement with statements related to treatment plan decisions on a scale from 0 (strongly disagree) to 5 (strongly agree), in 1-point increments. Higher scores indicate greater confidence and certainty in the decision-making process.
Shared Decision-Making Satisfaction Score	For the first 2 years, every 6 months, then every 6-12 months depending on the condition.	To assess patient satisfaction with the shared decision-making process with healthcare providers. Satisfaction is measured using a questionnaire rated on a scale from 0 (very dissatisfied) to 10 (very satisfied), with 1-point increments. Higher scores indicate greater satisfaction with the collaborative decision-making process.

Trial Locations

Locations (4)

National Cancer Center; 🇰🇷 Goyang-si, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

SMC-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of