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Enrolling by Invitation

NCT Number: NCT06261190

Active Surveillance for Low-risk Papillary Thyroid Carcinoma

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.

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Key information

Conditions

Thyroid Cancer Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Papillary Thyroid Carcinoma Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Center, Goyang-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Rate of disease progression between the active surveillance group and the immediate surgery group

    Time frame: At 5years, 10years after enrollment

    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.

Secondary outcomes

  1. Risk factors for disease progression in the active surveillance group

    Time frame: At 5years, 10years after enrollment

    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.

  2. Rate of conversion to surgery without disease progression in the active surveillance group

    Time frame: At 5years, 10years after enrollment

    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.

  3. Rate of Disease Progression Between the Immediate Surgery Group and the Surgery-After-Progression Group

    Time frame: At 5years, 10years after enrollment

    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.

  4. Factors influencing treatment decision-making

    Time frame: At 5years, 10years after enrollment

    To evaluate the factors influencing the decision to pursue active surveillance, undergo surgery, or modify the treatment.

  5. Decision Conflict Scale Score

    Time frame: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.

    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.

  6. Shared Decision-Making Satisfaction Score

    Time frame: For the first 2 years, every 6 months, then every 6-12 months depending on the condition.

    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.

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Collaborators

  • SMG-SNU Boramae Medical Center
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital

Registry information

Official study title

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

Acronym: MAeSTro-EXP

Important dates

Study start
2024
Primary completion
2029
Study completion
2032
First posted
Feb 15, 2024
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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