Detection of Early-Stage Lung Cancer in Sputum Using Flow Cytometry and an Automated Analysis Pipeline
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,063
- 试验地点
- 11
- 主要终点
- Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum
研究概览
简要总结
Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, >6 to <30 mm in Diameter, Determined by LDCT.
详细描述
Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, >6 to <30 mm in Diameter, Determined by LDCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is able to give signed informed consent and comply with study requirements.
- •Is high risk for getting lung cancer:
- •≥50 - 80 years of age.
- •current smoker with smoking history of at least 20 pack-years or current non-smoker with smoking history of at least 20 pack-years who quit smoking within the past 15 years.
- •Has a >6 to <30 mm diameter lung nodule (found by lung cancer screening or found incidentally by CT scan) as determined by CT and is willing to provide a sputum sample for FlowPath Lung test within 6 weeks of the prestudy baseline CT scan.
- •3a) Nodule is either new, increasing, or stable for ≤ 6 months. 3b) In cases where a person has multiple nodules as determined by CT scan, the subject's most suspicious nodule is >6 to <30 mm in diameter.
- •4) Is willing to provide contact information to the study PI or the treating physician(s) who can release required medical information related to SOC follow-up.
排除标准
- •Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease).
- •The dominant nodule is ground glass or part solid as determined by CT scan.
- •Has 5 or more nodules sized >4 mm.
- •The nodule sized >6 to <30 mm in diameter is a distal (subsegmental) endobronchial nodule or a perifissural nodule.
- •Is immunosuppressed.
- •Has rheumatoid arthritis.
- •Had lung cancer diagnosis in the past 5 years or any other cancer (other than non-melanoma skin cancer) in the past 2 years. A subject on long-term medications used for prevention of cancer, such as Tamoxifen for breast cancer, is not excluded.
- •Has angina with minimal exertion.
- •Is currently pregnant or planning on becoming pregnant during this study.
研究组 & 干预措施
Single
Diagnostic testing of sputum sample provided by subject
干预措施: Standard medical treatment (Other)
结局指标
主要结局
Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum
时间窗: From Baseline Sputum Sample provided by subject through 24 months follow up period.
Evaluate the clinical performance (positive percent agreement \[PPA/sensitivity\] and negative percent agreement \[NPA/specificity\]) of the FlowPath Lung test in predicting lung cancer from the sputum of high-risk individuals with lung nodules
次要结局
未报告次要终点