Electronic Nose (E-nose) Technology to Assess Pathologic Response and Post- Treatment Progression for Non-small Cell Lung Cancer: a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- pathological response (Cohort 1: stages II to IIIB)
研究概览
简要总结
The researchers are doing this study to test the ability of a new technology called breathprinting, or electronic nose (E-Nose), to measure changes in certain chemicals in the breath before and after standard neoadjuvant therapy in people with NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Untreated clinical stage I NSCLC amenable to upfront surgery
- •Untreated stage II to IIIB NSCLC amenable to neoadjuvant treatment followed by surgery
- •ECOG Performance Status of ≤2 Of note, the E-nose is a completely noninvasive technology (only breath samples are collected). Therefore, this intervention would have no effects on a developing human fetus. There are therefore no requirements for the study population related to contraception or pregnancy testing.
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 (stage II to IIIB NSCLC)
45 patients undergoing neoadjuvant treatment (stages II to IIIB) will undergo breath sampling (1) at baseline before any treatment, (2) 2 weeks after neoadjuvant therapy, (3) 2 weeks after surgery, (4) 6 months after surgery, and (5) every 6 months for the first 2 years. Blood sample collections will coincide with the breath collection schedule.
干预措施: Breath sample collection (Diagnostic Test)
Cohort 1 (stage II to IIIB NSCLC)
45 patients undergoing neoadjuvant treatment (stages II to IIIB) will undergo breath sampling (1) at baseline before any treatment, (2) 2 weeks after neoadjuvant therapy, (3) 2 weeks after surgery, (4) 6 months after surgery, and (5) every 6 months for the first 2 years. Blood sample collections will coincide with the breath collection schedule.
干预措施: Research blood collection (Diagnostic Test)
Cohort 2 (stage I NSCLC)
15 patients who are planned to undergo upfront surgery will undergo breath sampling (1) at baseline before upfront surgery, (2) 2 weeks after surgery, (3) 6 months after surgery, and (4) every 6 months for the first 2 years.
干预措施: Breath sample collection (Diagnostic Test)
结局指标
主要结局
pathological response (Cohort 1: stages II to IIIB)
时间窗: up to 2 years
obtained using E-nose technology, all patients who have pre-neoadjuvant treatment E-nose testing, pre-surgery E-nose testing, 2 week post-surgery E-nose testing, and E-nose testing every 6 months for 2 years will be considered evaluable for the primary endpoint of Major Pathologic Response (MPR). Patients with MPR confirmed on pathologic analysis will be considered to have had an MPR, whereas all other evaluable patients will be considered to have not had an MPR, in accordance with the intention-to-treat analysis.
progression (Cohort 1: stages II to IIIB)
时间窗: up to 2 years
Differences in VOC expression between time-point assessments will be calculated in terms of VOC percentage change from baseline to assess the magnitude of change among patients with and without progression, particularly at earlier time points. Here, progression is considered as a binary endpoint, where progression includes recurrence, disease progression, or death within 2 years.
progression (Cohort 2: Stage I)
时间窗: up to 2 years
Differences in VOC expression between time-point assessments will be calculated in terms of VOC percentage change from baseline to assess the magnitude of change among patients with and without progression, particularly at earlier time points. Here, progression is considered as a binary endpoint, where progression includes recurrence, disease progression, or death within 2 years.
次要结局
未报告次要终点