PROPHETIC Extended - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Extended Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- ctDNA mutation analysis
研究概览
简要总结
The goal of this exploratory study is understand the mechanisms of response to immunotherapy in Non-Small Cell Lung Cancer patients.
The investigators are going to search for correlation between specific biological features and response to immunotherapy, and to use those associations for developing an algorithm enabling to identify patients that could benefit from the immune check inhibitor based anti cancer treatment.
Patients will provide biological samples before and during their treatment, and clinical data will be collected.
详细描述
The goal of the study is to develop an algorithm that associates between biomarkers detected in biospecimen of NSCLC patients, and their:
- Response to treatment
- Clinical benefit parameters such as PFS and OS.
- Adverse events to immune check inhibitor therapy
- Biological mechanisms involved in response or resistance to immune check inhibitor therapy.
Patients will provide plasma, PBMCs, stool and tissue samples (where applicable) before and during treatment.
Clinical data, including disease history, given treatment, response evaluation and adverse events to the treatment will be recorded.
Samples will be analysed as follows -
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent prior to any study-specific procedures.
- •Male or female aged at least 18 years.
- •ECOG PS - 0/1-2.
排除标准
- •Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of treatment.
- •Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
结局指标
主要结局
ctDNA mutation analysis
时间窗: immediately after surgery
ctDNA mutation analysis
Plasma proteomic profile
时间窗: 24 months
Plasma proteins measurments
Epigenetic patterns
时间窗: 24 months
Characterization of Cell free DNA
Microbiome profiling
时间窗: 24 months
PBMC subpopulations exploration
Overall response (OR)
时间窗: month 24
OR as defined by RECIST 1.1 or any other validated clinical scale for response
次要结局
未报告次要终点