Active Surveillance on Papillary Thyroid Microcarcinoma

Thyroid Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02938702
• Other study ID #: 2520160010
• Status: Active, not recruiting
• Start date: May 2016
• Est. completion date: March 2030

Study information

• Verified date: April 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1211
• Est. completion date: March 2030
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Papillary Thyroid Microcarcinoma
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Progression of Thyroid Papillary Microcarcinoma	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	5 years
Secondary	Comparison of Progression Rate between Active Surveillance and Surgery Group	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	5 years