Autoantibodies Prevalence and Their Related-diseases During Checkpoint Inhibitor Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- development or increase level of rheumatoid factor
研究概览
简要总结
The use of Checkpoint inhibitors (ICIs) is rapidly expanding to the treatment of many cancer types. Autoimmunity and clinical autoimmune diseases represent adverse events of ICIs with variable severity and consequences. Clinical trials using ICIs have largely excluded patients with preexisting autoimmune diseases but the rate of autoimmune flares has been reported to be high in patients with preexisting autoimmune diseases in retrospective cohort studies. Moreover numerous retrospective cases and series reported ICI-related autoimmune diseases in patients without any previous autoimmune event.
To date, no study has prospectively evaluated the rate of biological and clinical autoimmunity in patients. Moreover, guidelines concerning autoantibodies monitoring in patients are subject of debate.
详细描述
The aim of this prospective study is to determine development or increase level frequencies of different types of autoantibodies in patients receiving ICI for the first time. The rate of clinical autoimmunes diseases development will also be recorded and correlated with autoantibodies prevalence before and during ICI treatment.
Results will help to determine the rate of biological and clinical autoimmune events induced by ICIs in unselected patients and will help to clarify autoimmunity screening strategy in this setting.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients receiving check point inhibitor for a neoplasic disease in a center that participates to the study during the inclusion period
- •patients who agree to participate in the study
- •adult patients (aged more than 18 years old)
排除标准
- •- previous treatment with check point inhibitor
研究组 & 干预措施
Patients receiving inhibitor checkpoint treatment
adult patients that will receive for the first time checkpoint inhibitor for a neoplasic disease in a center participating to the study
干预措施: Blood sample (Biological)
结局指标
主要结局
development or increase level of rheumatoid factor
时间窗: Month 6
Development of rheumatoid factor will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of rheumatoid factor will be defined by doubling the concentration of the antibody titer
development or increase level of anti-nuclear antibody
时间窗: Month 6
Development of anti-nuclear antibody will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of anti-nuclear antibody will be defined by increase of at least 2 dilutions of the antibody titer
development or increase level of Anti-thyroperoxydase antibodies
时间窗: Month 6
Development of anti-TSH receptor antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of anti-TSH receptor antibodies will be defined by doubling the concentration of the antibody titer
development or increase level of anti-cyclic citrullinated peptide antibodies
时间窗: Month 6
Development of anti-cyclic citrullinated peptide antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of anti-cyclic citrullinated peptide antibodies will be defined by doubling the concentration of the antibody titer
development or increase level of Anti-glutamic acid decarboxylase antibodies
时间窗: Month 6
Development of Anti-glutamic acid decarboxylase antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of Anti-glutamic acid decarboxylase antibodies will be defined by doubling the concentration of the antibody titer
development or increase level of Auto-antibodies associated with myositis
时间窗: Month 6
Development of Auto-antibodies associated with myositis antibodies will be defined by detection of autoantibodies above the positive threshold of the test if below the positive threshold initially (seroconversion) Increase level of Auto-antibodies associated with myositis antibodies will be defined by doubling the concentration of the antibody titer
次要结局
未报告次要终点