Papillary Thyroid Microcarcinoma, Thyroid Cancer
Conditions
Keywords
Active surveillance
Brief summary
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.
Interventions
None listed
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Progression of Thyroid Papillary Microcarcinoma | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Progression Rate between Active Surveillance and Surgery Group | 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 |
Countries
South Korea
Outcome results
None listed