Active Surveillance for Low-risk Papillary Thyroid Carcinoma

Launched by NATIONAL CANCER CENTER, KOREA · Feb 13, 2024

Keywords

ClinConnect Summary

This study in Korea (MAeSTro-EXP) is watching how a very small, low-risk papillary thyroid cancer behaves over time. It’s not a randomized trial. Instead, doctors and patients choose either ongoing active surveillance (watchful waiting with regular check-ups) or immediate surgery, and researchers collect information to compare outcomes over 5 and 10 years. The study also looks at how people decide between these options, how confident they feel about their choice, and how satisfied they are with shared decision-making with their doctors.

To be eligible, adults 18 and older with a thyroid tumor 1.5 cm or smaller and a biopsy result that supports cancer (Bethesda category V or VI) and no high-risk features (like neck or distant metastasis, or invasion of nearby structures) can join. Participants should be able to attend regular follow-up visits. The study is enrolling about 499 people at several centers in Korea, started in 2024, with primary results expected later in the decade and ongoing follow-up through the 2030s. If you’re in active surveillance and the cancer meets predefined criteria for progression (such as enough growth, a new cancer lesion, or signs of spread), surgery may be recommended. If you undergo immediate surgery, the cancer is treated up front and you’ll have regular follow-up to track outcomes.

Gender

ALL

Eligibility criteria

• 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.