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Active, Not Recruiting

NCT Number: NCT02938702

Active Surveillance on Papillary Thyroid Microcarcinoma

The study is a multi-center prospective cohort study of active surveillance in papillary thyroid cancer with low risk. The purpose of the study is to observe natural course of low risk papillary thyroid cancer in Korean population, and comparison of prognosis between active surveillance group and conventional surgery group. Patient will be well informed about their choice of active surveillance or surgery.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Papillary Thyroid Microcarcinoma Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • who agreed to the agreement form
  • who is older than 18 years old
  • who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category V or VI
  • whose thyroid cancer is smaller than 1 cm length

Exclusion criteria

  • who cannot routinely follow-up according to the study schedule
  • who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category I, II, III, or IV.
  • who have hyperthyroidism which needs treatment

Treatment and study plan

Primary outcomes

  1. Rate of Progression of Thyroid Papillary Microcarcinoma

    Time frame: 5 years

    rate of progression: tumor size increase of ≥3 mm in at least one dimension, tumor size increase of ≥2 mm in at least two dimensions, suspected organ involvement during the follow-up, such as trachea, esophagus, nerves, vessels, or muscles in imaging study including high-resolution ultrasonography, or pathological diagnosis of lymph node/distant metastasis

Secondary outcomes

  1. Comparison of Progression Rate between Active Surveillance and Surgery Group

    Time frame: 5 years

    Which group had higher progression rate; progression defined as whether tumor size increases more than 3 mm in diameter, or tumor involves new lymph nodes, or metastasis occurs

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2025
Study completion
2030
First posted
Oct 19, 2016
Registry last updated
Apr 25, 2022

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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