Idylla™ ThyroidPrint® RUO Assay Beta-Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary endpoints
研究概览
简要总结
To perform a post-market study of the performance of the Idylla™ ThyroidPrint® Assay using clinical samples in predicting the nature of indeterminate thyroid nodules (ITNs) across multiple centers.
详细描述
This is a multicenter, non-interventional (observational), prospective, post-market study, matching the Idylla™ ThyroidPrint® RUO Assay result to the gold standard of surgical pathology.
The study population is defined as cases where the thyroid nodule has been reported as indeterminate.
Primary endpoints are the calculation of the sensitivity, specificity, and the negative and positive predictive values of the Idylla™ ThyroidPrint® RUO Assay for indeterminate thyroid nodules.
Secondary endpoint: to assess the failure rate of Idylla™ ThyroidPrint® RUO Assay, including errors and invalids; describe the nature of false negative and false positive cases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Thyroid nodule ≥1.0 cm
- •With indeterminate cytology
- •Surgery due to be performed
排除标准
- •Specimens which fail to meet the inclusion criteria.
- •FNA fixed in formalin or transferred in alcohol-based collection buffers which is not according to the protocol instructions.
- •RNA extracts.
- •Patients with ultrasound evidence of malignant cervical adenopathy
结局指标
主要结局
Primary endpoints
时间窗: Samples taken at Baseline
to measure the accuracy of the Thyroid print test against the surgical pathology report.
次要结局
未报告次要终点