Use Peripheral Blood Proteomics to Predict the Treatment Response and Toxicities in NSCLC Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Treatment toxicities
研究概览
简要总结
Peripheral blood contains enormous quantity of biological information that can improve our patient care. Investigators plan to use proteomics from serum to study its value in predicting the therapeutic response and toxicities of immunotherapy in non-small cell lung cancer (NSCLC).
详细描述
An extra tube of blood for research will be collected from consented subjects prior to the initiation of anti-PD-1/L1 based immunotherapy, either single agent or in combination with chemotherapy. The blood will be coded, processed and sent for analysis. Results of analysis will be correlated with clinical data to see whether serum proteomics can be a good therapeutic predictor for future studies and treatments of NSCLC.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Non Small Cell Lung Cancer (NSCLC) patients who were previously untreated receiving anti-PD1 or anti-PD-L1 therapies, either single agent or in combination with chemotherapy.
- •NSCLC patients who were treated with one previous line of therapy (not containing IO) and now receiving anti-PD1 or anti-PD-L1 therapies, either single agent or in combination with chemotherapy.
排除标准
- •Patients not capable of making medical decisions
- •Any patients who do not meet the inclusion criteria
结局指标
主要结局
Treatment toxicities
时间窗: Time of study enrollment up to one year
The treatment toxicities will be recorded using CTCAE version 5.0
Treatment response
时间窗: Time of study enrollment up to one year
Treatment response will be measured every 2-3 months using iRECIST criteria.
Correlate peripheral blood proteomics data with patients' clinical information
时间窗: Time of study enrollment up to one year
An extra tube of peripheral blood (\~10ml) will be collected prior to the treatment. This blood specimen will be spun down and the serum collected and aliquoted. \~1ml serum will be shipped to Biodesix Inc. for the analysis of blood proteomics using matrix-assisted laser/desorption ionization (MALDI) mass spectrometry. We will correlate proteomics data with patients clinical information including treatment response, toxicities, tumor mutation/PD-L1 status, etc. to determine if peripheral blood protemoics can predict therapeutic response.
次要结局
未报告次要终点
研究者
Muhammad Furqan
Clinical Associate Professor
University of Iowa