Clinical trial NCT06261190: Active Surveillance for Low-risk Papillary Thyroid Carcinoma
Official title: Study Protocol of Extended Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Carcinoma (MAeSTro-EXP)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Thyroid Cancer
Papillary Thyroid Carcinoma
Keywords: Active Surveillance
Immediate surgery
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Seoul National University Bundang Hospital
name: SMG-SNU Boramae Medical Center
name: Seoul National University Hospital
First posted: 2024-02-15
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects aged older than 18 years with the tumor size of ≤ 1.5 cm papillary thyroid carcinoma, who meet the inclusion criteria from Seoul National University Hospital, National Cancer Center, Seoul National University Bundang Hospital, and SMG-SNU Boramae Medical Center.

Brief 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.

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.

Primary outcomes:
measure: Rate of disease progression between the active surveillance group and the immediate surgery group
timeFrame: At 5years, 10years after enrollment
Secondary outcomes:
measure: Risk factors for disease progression in the active surveillance group
timeFrame: At 5years, 10years after enrollment
measure: Rate of conversion to surgery without disease progression in the active surveillance group
timeFrame: At 5years, 10years after enrollment
measure: Rate of Disease Progression Between the Immediate Surgery Group and the Surgery-After-Progression Group
timeFrame: At 5years, 10years after enrollment
measure: Factors influencing treatment decision-making
timeFrame: At 5years, 10years after enrollment
measure: Decision Conflict Scale Score
timeFrame: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.
measure: Shared Decision-Making Satisfaction Score
timeFrame: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SMC-SNU Boramae Medical Center
Study officials:
References: