NCT06261190

Active Surveillance for Low-risk Papillary Thyroid Carcinoma

Study Protocol of Extended Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Carcinoma (MAeSTro-EXP)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 499 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid Cancer
• Papillary Thyroid Carcinoma

Timeline

• Start date: 2024-03-06
• Primary completion: 2029-12-31
• Completion: 2032-12-31
• First posted: 2024-02-15
• Last updated: 2025-05-11

Locations

4 sites across 1 country: South Korea