Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer. (SCHISM)
Immunotherapy, which can be represented by the immune checkpoint blockade, is a milestone in the progress of the ongoing struggle against cancer. However, the emergence of unexpected tumor response patterns, such as pseudo-progression or hyper-progression, might complicate the management of patients receiving these immune checkpoint inhibitors. A reliable standardized biomarker that can be used in clinical practice for predicting response to treatment, monitoring tumor evolution and evaluating treatment efficacy has not yet been established.
The general aim of this study is to assess the interest of the plasmatic free circulating DNA (cfDNA) on the clinical response for patients with different types of cancer treated with immunotherapies. The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate.
研究概览
地位
条件
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Sebastien Salas, Professor
- 邮箱：sebastien.salas@ap-hm.fr
学习地点
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Marseille、法国
- 招聘中
- APHM
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接触：
- Sebastien Salas, MD
- 邮箱：sebastien.salas@ap-hm.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients starting anti-PD1 immunotherapy as part of marketing authorization alone or in combination (melanoma, clear cell renal cancer, urothelial carcinomas of the bladder, squamous cell carcinomas of the head and neck and non-small cell lung cancer).
- No contraindications to immunotherapy
- Non-pregnant patient
- Patient not opposed to participation in this study
Exclusion Criteria:
- HIV seropositivity
- Patient with psychiatric or other conditions that may compromise his or her ability to give non opposition or to follow study procedures
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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黑色素瘤
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clear cell renal cancer
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Urothelial Carcinoma of the bladder
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squamous cell carcinomas of the head and neck
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non-small cell lung cancer
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Interest of the plasmatic free circulating DNA (cfDNA)
大体时间：At first evaluation, then 1 administration over 2 for 1 year then at 18 months and an additional sample will be taken at the time of recurrence
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The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate
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At first evaluation, then 1 administration over 2 for 1 year then at 18 months and an additional sample will be taken at the time of recurrence
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2020-048
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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