Specific Biomarkers of Immune-mediated Hepatitis Secondary to Immune Checkpoint
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Determination of the area under the ROC (Receiver Operation characteristic) curve for hepatitis.
研究概览
简要总结
Identify specific blood biomarkers for hepatitis induced by immune checkpoint inhibitors in comparison to idiopathic autoimmune hepatitis.
详细描述
Immune checkpoint inhibitors (ICI) have become a pillar of the oncological therapeutic arsenal. Their mechanism of action is based on the restoration of the innate anti-tumor function of T lymphocytes. This mode of action is also the cause of systemic immune-mediated adverse effects. The most common disorders are endocrine, cutaneous and gastrointestinal. The frequency of hepatic toxicities is estimated between 0.7 and 25% depending on the studies, the cancer treated and the ICI combinations used. Currently the description of these hepatitis is brief in the literature and the mechanism of toxicity is not known. Work has already compared histological damage between immune checkpoint inhibitors (CHILI) and autoimmune hepatitis; The investigators find in CHILI a higher ratio of CD8 + /CD4 + lymphocytes. Apart from these clinical, biological or histological descriptions, knowledge is limited. In particular, there are no known predictive factors or prognoses.
The investigators hypothesize that there are mechanistic differences between checkpoint inhibitors induced liver injury and idiopathic autoimmune liver disease. Proteomic analysis is a powerful tool for functional analysis.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CHILI : hepatitis induced by immune checkpoint inhibitors
Patient with immunotherapy-induced hepatitis
干预措施: Blood sample collection (Biological)
CHILI : hepatitis induced by immune checkpoint inhibitors
Patient with immunotherapy-induced hepatitis
干预措施: Liver biopsy (Procedure)
Control group: idiopathic autoimmune hepatitis
Patient with idiopathic autoimmune hepatitis
干预措施: Blood sample collection (Biological)
Control group: idiopathic autoimmune hepatitis
Patient with idiopathic autoimmune hepatitis
干预措施: Liver biopsy (Procedure)
结局指标
主要结局
Determination of the area under the ROC (Receiver Operation characteristic) curve for hepatitis.
时间窗: Baseline
Sensitivity/specialty curve of blood biomarkers identification and expression level by proteomic analysis, specific to immunotherapy-induced hepatitis (CHILI group), versus idiopathic autoimmune hepatitis (control group).
次要结局
- Determination of the area under the ROC (Receiver Operation characteristic) curve for treatment response(Baseline, day 14, day 28, month 3, month 6)
- Responses to treatments(Day 28)
