Active Surveillance on Papillary Thyroid Microcarcinoma

N/AActive Not RecruitingNCT02938702

Seoul National University Hospital1,211 enrolled

Overview

The study is a multi-center prospective cohort study of active surveillance in papillary thyroid cancer with low risk. The purpose of the study is to observe natural course of low risk papillary thyroid cancer in Korean population, and comparison of prognosis between active surveillance group and conventional surgery group. Patient will be well informed about their choice of active surveillance or surgery.

Study Type

OBSERVATIONAL

Enrollment

1,211

Conditions

Thyroid Cancer Papillary Thyroid Microcarcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * who agreed to the agreement form * who is older than 18 years old * who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category V or VI * whose thyroid cancer is smaller than 1 cm length Exclusion Criteria: * who cannot routinely follow-up according to the study schedule * who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category I, II, III, or IV. * who have hyperthyroidism which needs treatment

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Rate of Progression of Thyroid Papillary Microcarcinoma

rate of progression: tumor size increase of ≥3 mm in at least one dimension, tumor size increase of ≥2 mm in at least two dimensions, suspected organ involvement during the follow-up, such as trachea, esophagus, nerves, vessels, or muscles in imaging study including high-resolution ultrasonography, or pathological diagnosis of lymph node/distant metastasis

Time frame: 5 years

Secondary Outcomes

Comparison of Progression Rate between Active Surveillance and Surgery Group

Which group had higher progression rate; progression defined as whether tumor size increases more than 3 mm in diameter, or tumor involves new lymph nodes, or metastasis occurs

Time frame: 5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.