NCT05171491进行中（未招募）不适用
Clinical Evaluation of LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
LungLife AI12 个研究点 分布在 1 个国家目标入组 425 人开始时间: 2022年1月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 425
- 试验地点
- 12
- 主要终点
- Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy.
研究概览
简要总结
Correlate performance of LungLB Test with outcome of a scheduled biopsy.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old with a CT identified indeterminate pulmonary nodule and scheduled for biopsy, at the time of consent.
- •Planned biopsy nodule of interest:
- •is solid ≤3 cm; or
- •is nonsolid, ground glass opacity, of any size; or
- •is part solid, where the solid component is no larger than 3cm (maximum diameter).
排除标准
- •Current and or prior diagnosis +/- treatment of non-lung cancer within the past 3 years.
- •Current and or prior lung cancer diagnosis within 2 years following intent-to-cure surgery.
结局指标
主要结局
Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy.
时间窗: up to 60 days
次要结局
- Evaluate Clinical Variables With and Without LungLB Test Results(up to 60 days)
研究者
研究点 (12)
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