Active Surveillance for Low-risk Papillary Thyroid Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Thyroid Cancer, Papillary Thyroid Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study Protocol of Extended Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Carcinoma (MAeSTro-EXP)
Overview
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.
Primary outcome measures
- Rate of disease progression between the active surveillance group and the immediate surgery group [Time frame: At 5years, 10years after enrollment]
Secondary outcome measures (6)
- Risk factors for disease progression in the active surveillance group [Time frame: At 5years, 10years after enrollment]
- Rate of conversion to surgery without disease progression in the active surveillance group [Time frame: At 5years, 10years after enrollment]
- Rate of Disease Progression Between the Immediate Surgery Group and the Surgery-After-Progression Group [Time frame: At 5years, 10years after enrollment]
- Factors influencing treatment decision-making [Time frame: At 5years, 10years after enrollment]
- Decision Conflict Scale Score [Time frame: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.]
- Shared Decision-Making Satisfaction Score [Time frame: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 4 centers
- National Cancer Center — Goyang-si
- Seoul National University Bundang Hospital — Seongnam
- Seoul National University Hospital — Seoul
- SMC-SNU Boramae Medical Center — Seoul
Identifiers
NCT: NCT06261190 · H-2308-182-1463