Pilot Study: Metabolic and Microbial Profiling of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Participants Needed for Feasibility
研究概览
简要总结
This pilot study will establish non-invasive sample collections, including breath, saliva, blood and urine pre-surgery and at the participant's one-month post-surgery follow-up visit. Participants with suspected non-small cell lung cancer (NSCLC) stage I-III will be recruited.
详细描述
Primary Objective
- To evaluate the feasibility of adding non-invasive sample collections in the pre-surgical setting and at the post-surgery follow-up visit.
- To identify and assess metabolic and microbial signatures collected at pre- and post-surgery and determine which are indicative of lung cancer.
Secondary Objective
- To identify signatures which are associated with lung cancer stage.
- To identify signatures which are impacted by patient's pulmonary function status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Male and female patients age >18 years, of all racial and ethnic origins, with suspected nonsmall cell lung cancer stages I, II, and III, as evident through radiographic evidence and felt acceptable to undergo surgical resection.
- •Patients who have the ability to understand and the willingness to sign a written consent form.
排除标准
- •Patients who are have taken antibiotics within two weeks.
- •Patients who are on continuous supplemental oxygen.
- •Patients currently undergoing active treatment for other malignancies.
- •Subjects who are unable or unwilling to provide consent.
结局指标
主要结局
Number of Participants Needed for Feasibility
时间窗: One month
The primary objectives is to assess the feasibility of adding these non-invasive sample collections to pre- and post-surgery visits the following outcomes (counts) will be gathered - (number eligible for trial, number that consent to participate, number that provide pre-surgery samples, number that provide post-surgery samples) using a 95% exact Clopper-Pearson confidence interval for each feasibility estimate.
Pre-Surgery and Post-Surgery Metabolic Signatures
时间窗: One month post surgery
Metabolic assessments will be taken before and after surgery of lung cancer biomarkers to examine a series of paired t-tests to determine which markers significantly change between the two time points for participants.
Pre-Surgery and Post-Surgery Microbial Signatures
时间窗: One month post surgery
Metabolic assessments will be taken before and after surgery of lung cancer biomarkers to examine a series of paired t-tests to determine which markers significantly change between the two time points for participants.
次要结局
- Identification of Signatures Associated With Pulmonary Function(One month post surgery)
- Identification of Lung Cancer Stage Specific Signatures(One month post surgery)