Genomic Predictors of Papillary Microcarcinoma Disease Progression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- estimate the disease progression rate
研究概览
简要总结
The study is being done to answer the following question: What are the specific clinical and molecular features that will help us predict which small thyroid cancers are likely to grow and be problematic?
Therefore, the purpose of this study is to identify specific clinical and molecular characteristics that are predictive of tumor progression in small thyroid cancers.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven papillary thyroid cancer (or suspicious for papillary thyroid cancer) confirmed by MSKCC cytopathologist.
- •Being followed with active surveillance at MSKCC
- •Biopsied index nodule less than or equal to 2 cm in maximum dimension
- •Thyroid and neck US performed and interpreted by a MSKCC radiologist within 6 months prior to study entry.
排除标准
- •Biopsied index nodule greater than 2 cm in any dimension
- •Age less than 18 yrs old
研究组 & 干预措施
Papillary Microcarcinoma
This clinical trial protocol describes implementation of a prospective observation protocol to standardize data collection and obtain permission to collect samples of PMC tumors in a cohort of PMC patients being followed with active surveillance. This will allow PMC tumors to be accurately classified as either stable or progressive over time and used for comprehensive molecular profiling if surgical removal is required during follow-up
结局指标
主要结局
estimate the disease progression rate
时间窗: 4 years
Therefore, in order to ensure that we will have at least 459 patients with PTC being followed with active surveillance, we plan to enroll 500 total patients, of which 350 will have FNA diagnostic for PTC (of which 99% are expected to have PTC) and 150 patients will have FNA suspicious for PTC (of which 113 would be expected to have PTC). This sample size will enable us to estimate the 5 year disease progression rate requiring intervention to within ±4% at 95% confidence level (using binomial calculation under the assumption that the study is not stopped early and the progression rate is not higher than 10%).
次要结局
未报告次要终点