Active Surveillance of Papillary Thyroid MicroCarcinoma

Not Applicable

Active, not recruiting

• Conditions: Neoplasms

• Registration Number: KCT0004935
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1) Age 19-79 years
2) Thyroid nodules sized 6-10 mm by ultrasound within three months
3) Thyriod nodules confirmed by fine needle biopsy guided ultrosound or core needle biopsy as having Bethesda category V or VI cytology (or histopathology) within 1 year.
: If cytology (or histopathology) showed Bethesda category V, the nodule should show high suspicion ultrasound features by K-TIRADS system or have BRAF V600E mutation.

Exclusion Criteria

1) People who have difficulty understanding the study (e.g. an illiterate, decreased vision)
2) Pregnant
3) People having other chronic disease or other uncontrolled cancers
- Excluding eGFR<30mL/min/1.73m2
- Other condition can be enrolled if it doesn't affect PTMC treatment progress and result by the investigator's decision.
4) People who need total thyroidectomy due to multiple nodules or other thyroid disease
5) Thyroid nodules showing (suspecting) metastases, invasion to extrathyroidal organs, bronchus, muscles or nurves(vocal cords paralysis)

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
Overall survival according to the treatment;Risk factors of disease progression during active surveillance: age, sex, and ultrasound features;Proportion of patients who change their treatment option from active surveillance to surgery without disease progression: Analyze reasons for changing of mind by questionnaires;Changes in quality of life questionnaire scores according to the treatment and follow-up periods;Cost-effective analysis according to the treatment;Surgical outcomes analysis according to the treatment: Extent of surgery, complications of surgery;Appropriate courses(intervals) for imaging during active surveillance