A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 25
- 主要终点
- Lung Nodule Diagnosis
研究概览
简要总结
This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.
详细描述
A multicenter, randomized controlled study with a blinded control arm. Open label arm is observational for lung nodule management. The clinical trial will evaluate the clinical utility of the Nodify XL2 integrated classifier when used in the clinical management of newly identified solid lung nodules assessed as < 50% risk of cancer by Mayo risk prediction algorithm.
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
- •Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements
- •Subject is > 40 years of age at the time of the discovery of the lung nodule of concern
- •Subject's lung nodule of concern meets the following:
- •Was incidentally identified or detected during lung cancer screening
- •Is a solid nodule
- •Has maximal dimension of > 8mm and < 30mm
- •The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment
- •The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less
排除标准
- •Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern
- •Nodule of concern is part-solid or Ground Glass Opacity (GGO)
- •Prior diagnosis of lung cancer
- •Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer
- •Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment
- •Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern
- •Any illness or factor that will inhibit compliance with study participation
结局指标
主要结局
Lung Nodule Diagnosis
时间窗: Up to 24 months
Malignant diagnosis through histology/pathology or benign diagnosis through histology/pathology, radiologic stability or radiologic confirmation of nodule resolution
次要结局
未报告次要终点