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Enrolling by invitation Observational

Active Surveillance for Low-risk Papillary Thyroid Carcinoma

NCT06261190 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2024-03-06
Last updated
2025-05-11

Condition(s) studied

Thyroid CancerPapillary Thyroid Carcinoma

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (4)

FacilityCityRegionStatus
National Cancer Center Goyang-si South Korea
Seoul National University Bundang Hospital Seongnam South Korea
Seoul National University Hospital Seoul South Korea
SMC-SNU Boramae Medical Center Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06261190 on ClinicalTrials.gov ↗ ← All trials in South Korea