Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| SMG-SNU Boramae Medical Center | OTHER |
| Seoul National University Hospital | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active surveillance | Group with active surveillance of their Papillary Thyroid Cancer | ||
| Immediate surgery | Group who underwent surgery after diagnosis Papillary Thyroid Cancer |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Rate of disease progression between the active surveillance group and the immediate surgery group | 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. | At 5years, 10years after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Risk factors for disease progression in the active surveillance group | 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. | At 5years, 10years after enrollment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects aged older than 18 years with the tumor size of ≤ 1.5 cm papillary thyroid carcinoma, who meet the inclusion criteria from Seoul National University Hospital, National Cancer Center, Seoul National University Bundang Hospital, and SMG-SNU Boramae Medical Center.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | South Korea | ||||
| Seoul National University Bundang Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Rate of conversion to surgery without disease progression in the active surveillance group |
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. |
| At 5years, 10years after enrollment |
| Rate of Disease Progression Between the Immediate Surgery Group and the Surgery-After-Progression Group | 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:
| At 5years, 10years after enrollment |
| Factors influencing treatment decision-making | To evaluate the factors influencing the decision to pursue active surveillance, undergo surgery, or modify the treatment. | At 5years, 10years after enrollment |
| Decision Conflict Scale Score | 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. | For the first 2 years, every 6 months, then every 6-12 months depending on the condition. |
| Shared Decision-Making Satisfaction Score | 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. | For the first 2 years, every 6 months, then every 6-12 months depending on the condition. |
| Seongnam |
| South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| SMC-SNU Boramae Medical Center | Seoul | South Korea |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000231 | Adenocarcinoma, Papillary |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |