Active Surveillance for Low-risk Papillary Thyroid Carcinoma (MAeSTro-EXP)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Papillary Thyroid Carcinoma; Thyroid Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 499

Contacts and Locations

Study Locations

• Korea, Republic of
  • Goyang-si, Korea, Republic of
    • National Cancer Center
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • SMC-SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Active surveillance; Group with active surveillance of their Papillary Thyroid Cancer
Immediate surgery; Group who underwent surgery after diagnosis Papillary Thyroid Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of disease progression between the active surveillance group and the immediate surgery group	Disease progression in the following criteria: (1) a size increase of ≥3 mm in maximum diameter or size increase of ≥2 mm in two diameters; (2) a cytopathological diagnosis of a new thyroid cancer lesion; (3) a cytopathological diagnosis of a cervical lymph node metastasis; or (4) clinical or radiological suspicion of a distant metastasis.	At 5years, 10years after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for disease progression in the active surveillance group	To evaluate the risk factors for progression to thyroid cancer based on demographic factors, serial ultrasound findings, blood markers, and molecular pathological characteristics at each follow-up visit.	At 5years, 10years after enrollment
Rate of conversion to surgery without disease progression in the active surveillance group	To estimate the proportion of patients in the active surveillance group who undergo surgery without clinical evidence of progression to thyroid cancer, evaluated at each follow-up visit.	At 5years, 10years after enrollment
Rate of Disease Progression Between the Immediate Surgery Group and the Surgery-After-Progression Group	The outcome will be measured as the proportion (%) of patients in each group who experience disease progression at each follow-up visit. Disease progression is defined as meeting any of the following criteria: an increase in tumor size of ≥3 mm in maximum diameter, or ≥2 mm in two perpendicular diameters;; a cytopathological diagnosis of a new thyroid cancer lesion;; a cytopathological diagnosis of cervical lymph node metastasis;; clinical or radiological suspicion of distant metastasis.	At 5years, 10years after enrollment
Factors influencing treatment decision-making	To evaluate the factors influencing the decision to pursue active surveillance, undergo surgery, or modify the treatment.	At 5years, 10years after enrollment
Decision Conflict Scale Score	The level of confidence in decision-making will be assessed at each follow-up visit using the Decision Conflict Scale. This questionnaire evaluates the level of agreement with statements related to treatment plan decisions on a scale from 0 (strongly disagree) to 5 (strongly agree), in 1-point increments. Higher scores indicate greater confidence and certainty in the decision-making process.	For the first 2 years, every 6 months, then every 6-12 months depending on the condition.
Shared Decision-Making Satisfaction Score	To assess patient satisfaction with the shared decision-making process with healthcare providers. Satisfaction is measured using a questionnaire rated on a scale from 0 (very dissatisfied) to 10 (very satisfied), with 1-point increments. Higher scores indicate greater satisfaction with the collaborative decision-making process.	For the first 2 years, every 6 months, then every 6-12 months depending on the condition.

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Collaborators: Seoul National University Hospital; Seoul National University Bundang Hospital; SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Active Surveillance; Immediate surgery
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Adenocarcinoma, Papillary; Thyroid Cancer, Papillary; Thyroid Diseases; Carcinoma; Thyroid Neoplasms
• Other Study ID Numbers: H-2308-182-1463

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No