A Single-Center, Prospective, Observational Trial to Analyze the Relationship Between Single Nucleotide Polymorphism rs2910164 and the Efficacy and Safety of Immune Checkpoint Inhibitor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The objective of this study is to investigate whether the SNP rs2910164 in the pre-miR-146a gene is associated with outcome and toxicity of immune checkpoint inhibitor therapy.
详细描述
The single nucleotide polymorphism (SNP) rs2910164 within the gene for microRNA-146a (miR-146a) reduces miR-146a expression. Previous studies of the investigators demonstrated that this SNP was associated with increased acute GvHD severity in patients undergoing allogeneic hematopoietic stem cell transplantation. In this prospective, observational study the investigators aim to analyze, whether SNP rs2910164 is associated with severity of immune-related adverse events of immune checkpoint inhibitor therapy. Moreover, association of rs2910164 with outcome parameters will be studied.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of cancer
- •treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1 or anti-CTLA4)
- •age ≥ 18 years
- •peripheral blood sample available
- •written informed consent
- •ability to understand the nature of the study and the study related procedures and to comply with them
排除标准
- •age < 18 years
- •lack of informed consent
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 2 years
Severity of immune-related adverse events (irAEs)
时间窗: 2 years
according to CTCAE
次要结局
未报告次要终点
研究者
Robert Zeiser
Head of Department of Tumorimunnology and Immunoregulation
University of Freiburg