Active Surveillance on Papillary Thyroid Microcarcinoma

Active, not recruiting

• Conditions: Papillary Thyroid Microcarcinoma; Thyroid Cancer

• Registration Number: NCT02938702
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-17
• Study Start: 2016-05
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-25
• Primary Completion: 2025-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1211

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Progression of Thyroid Papillary Microcarcinoma	5 years	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

Secondary Outcome Measures

Name	Time	Method
Comparison of Progression Rate between Active Surveillance and Surgery Group	5 years	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

Trial Locations

Locations (1)

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