A Pilot Study of Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis After Chemoradiotherapy For Stage III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Variability of Biomarkers
研究概览
简要总结
This is a prospective pilot study investigating exhaled breath condensate analyses to quantify the variability over time of various biomarkers associated with symptomatic pneumonitis.
详细描述
Primary Objective:
• To quantify the intra-person variability of concentrations of TGF-β1, IL-6, IL-1α, and IL-10 measured in exhaled breath condensate.
Secondary Objectives:
- To examine the associations between differences in pre-treatment and post-treatment exhaled breath condensate concentrations of TGF-β1, IL-6, IL-1α, and IL-10 and the development of CTCAE grade 2+ symptomatic pneumonitis.
- To examine the associations between serum measures of TGF-β1, IL-6, IL-1α, and IL-10 and:
- Exhaled breath condensate measures of the same biomarkers, and
- The development of CTCAE grade 2+ symptomatic pneumonitis.
- To examine the association between microbiome signatures found in pre-treatment exhaled breath condensate and the development of CTCAE grade 2+ symptomatic pneumonitis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years old.
- •Clinically diagnosed or suspected Stage III non-small cell lung cancer to be treated with chemoradiotherapy as part of cancer treatment, as determined by the treating clinician.
- •Plan for treatment with definitive radiotherapy (≥60 Gy) with concurrent chemotherapy at the discretion of the treating radiation and medical oncologists.
- •Willing and able to tolerate exhaled breath collection.
- •Able to provide informed consent.
排除标准
- •Systemic (oral, intravenous or intramuscular) corticosteroid use for any reason within 5 days of registration.
- •Prior radiotherapy directed at the chest (thoracic inlet superiorly to diaphragm inferiorly).
- •Any systemic antibiotic use within 2 weeks of registration.
结局指标
主要结局
Variability of Biomarkers
时间窗: At baseline and one month after completion of chemotherapy
Concentrations of TGF-β1, IL-6, IL-1α, and IL-10 (ng/mL) will be measured in exhaled breath condensate at baseline, at 2 weeks and after chemotherapy start and 6 weeks after chemotherapy start (the end of chemotherapy) and 1 month after completion of chemotherapy using a 2-tailed alpha of 0.05 with detectable standard deviation units from baseline to post treatment.
次要结局
- Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT(One month after completion of chemotherapy)