Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPI
研究概览
简要总结
Checkpoint inhibitors represent a new class of widely used immunotherapy, however with immune-mediated adverse effects, with renal damage estimated at 1.4% and 4.9% depending on the series.
Acute tubulointerstitial nephritis (ATNI) represents the most common type of damage, although there are other types of damage, associated or not with NTIA.
We aim to establish a probability score for the presence of histological NTIA lesions in a patient treated with CPI who presents with acute renal failure in order to guide the nephrologist and oncologist in their management in the event of AKI at the CPI, and determine the usefulness of a PBR to guide the suspension/resumption of immunotherapy +/- associated corticosteroid therapy; avoiding a PBR exposing to a high iatrogenic risk and sometimes impossible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patient over 18 years old Diagnosis of solid cancer treated by immunotherapy such as checkpoint inhibitor, associated or not with chemotherapy Renal failure having benefited from a renal biopsy
排除标准
- 未提供
结局指标
主要结局
Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPI
时间窗: between January 2020 and December 2024
次要结局
未报告次要终点