NCT07822217进行中（未招募）不适用
Active Surveillance of Small Thyroid Cancers.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Treatment
研究概览
简要总结
Patients with a single, small (less than 2 cm) cancer nodule in the thyroid gland will be offered active surveillance initially for 5 years. In case of cancer growth or changes in ultrasonographic appearance, further treatment will be offered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of 30 years or older AND
- •single, well-defined tumor in the thyroid gland, with a FNAB suspicious of cancer or diagnostic of cancer (category V or VI in the Bethesda system) AND
- •tumor size of 2 cm or less in all dimensions.
排除标准
- •suspicion of disseminated disease because of:
- •PET-positive lymph nodes on the neck
- •suspicious lymph-nodes by neck ultrasonography (US)
- •signs of capsular invasion of the tumor
- •suspicion of metastatic disease due to findings on PET-CT-scan or thoracic CT-scan; OR
- •tumor placement at a high-risk location (in the thyroid capsule or near the trachea) OR
- •previous thyroid surgery OR
- •concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol/L) OR
- •if the patient is pregnant OR
- •If the patient is unable to give informed consent.
研究组 & 干预措施
Active surveillance
Above 30 years-of-age; one tumor suspicious for or diagnosed with malignancy (BSRTC V/VI); tumor 2 cm or less in widest diameter; cN0 and cM0.
结局指标
主要结局
Treatment
时间窗: 24 months
The need for treatment due to tumor growth within 24 months (cumulative incidence)
次要结局
未报告次要终点
研究者
研究点 (1)
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