NCT04063501招募中不适用
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Microbiota signatures in stool
研究概览
简要总结
This study will prospectively collect airway, stool, and blood samples on 80 subjects with lung cancer undergoing immunotherapy. Investigators will evaluate airway/stool microbial signatures associated with local (lower airway) and systemic (blood) immune tone.They will then study whether microbiota and/or host signatures predict subjects' response by longitudinal assessment of the progression free survival. They will also repeat sampling after 8 weeks of immunotherapy to expand our mechanistic understanding of the response to treatment.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a diagnosis of advanced stage unresectable Non-Small Cell Lung Cancer and indication for PD-1 blockade treatment (either as monotherapy or combined with chemotherapy)
排除标准
- •Antibiotic, steroid, or chemotherapy received within the prior month since these are possible confounders that may impact the microbiome and the host immunity.
- •Brain metastasis (as evaluated by MRI obtained as part of standard of care staging evaluation)
- •FEV1<50% predicted
- •Cardiovascular disease (defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure)
- •Renal disease
- •Coagulopathy
- •Liver disease
结局指标
主要结局
Microbiota signatures in stool
时间窗: 3 Years
Progression-free survival (PFS)
时间窗: 3 Years
over ≥ 1-year follow-up
Microbiota signatures in lower and upper airways
时间窗: 3 Years
次要结局
未报告次要终点
研究者
研究点 (1)
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