Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 23
- 主要终点
- Number of invasive diagnostic procedures
研究概览
简要总结
The goal of this observational study is to learn how a physician uses the results of the Percepta® Nasal Swab test to manage people with a newly identified pulmonary nodule.
The main questions it aims to answer are:
- Does the use of the Percepta Nasal swab test reduce the number of invasive procedures in people with a low-risk result and whose nodule is benign?
- Does the use of the Percepta Nasal swab test decrease the time to treatment in people with a high-risk result and whose nodule is cancer?
Participants will be randomly assigned to either a group where the test result is provided to the physician (test arm) or to a group where the test result is not provided (control arm). Researchers will compare management of participants in the two groups.
详细描述
This is a prospective, multicenter, randomized study to evaluate the clinical utility of the Percepta® Nasal Swab classifier in managing patients with pulmonary nodules identified incidentally or by lung cancer screening. Patients will be randomized to either the test group, where the test result will be returned to the physician to incorporate into decision-making on how to manage the patient's nodule, or the control group which will represent the standard of care where the result will not be returned to the physician. The study will observe and evaluate how the addition of the Percepta Nasal Swab classifier result impacts current management of newly identified lung nodules.
The study will enroll approximately 2400 participants meeting eligibility criteria at up to 100 centers in the US. Enrollment is expected to take approximately 24 months and participants will be followed for 24 to 30 months or until a diagnosis of lung cancer.
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
- 29 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to tolerate nasal epithelial specimen collection
- •Signed written Informed Consent obtained
- •Subject clinical history available for review by sponsor and regulatory agencies
- •New nodule identified on imaging < 90 days prior to nasal sample collection
- •CT report available for index nodule
- •29 - 85 years of age
- •Current or former smoker (>100 cigarettes in a lifetime)
- •Pulmonary nodule ≤30 mm detected by CT
排除标准
- •Active cancer (other than non-melanoma skin cancer)
- •Prior primary lung cancer (prior non-lung cancer acceptable)
- •Prior participation in this study (i.e., subjects may not be enrolled more than once)
- •Current active treatment with an investigational device or drug
- •Patient enrolled or planned to be enrolled in another clinical trial that may influence management of the patient's nodule
- •Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy other than clinically validated risk calculators
结局指标
主要结局
Number of invasive diagnostic procedures
时间窗: From date of randomization until the date the nodule is diagnosed as benign or demonstrates up to 24 months radiographic stability or resolution, assessed up to a total of 30 months.
Invasive diagnostic procedures performed in the diagnostic workup of newly identified nodules that are benign.
次要结局
- Time to treatment(From date of randomization until the date of first documented treatment for lung cancer, assessed up to a total of 30 months.)