Relationship Between Immunity and Metabolism in Patients Receiving Immune Checkpoint Inhibitors for Advanced Cancer. ( RIMEC ) (RIMEC)
Assessment of Metabolic and Immune Profiles in Patients Receiving Immune Checkpoint Inhibitors (ICI) for Advanced Renal Cell Carcinoma or Lung Carcinoma.
Recent EMA and FDA approvals have made immune checkpoint inhibitors (ICI) a standard of care in cancer treatment. ICI, used alone or as a combination are now the backbone of renal cell and lung carcinoma treatment. However, a significant proportion of patients does not respond to ICI. Thus the identification of predictive response factor is a major issue.
While factors associated with the tumour and its micro environment have been widely studied, factors associated with the patient such as metabolism could also affect the response to ICI and remain poorly studied.
The hypothesis of the investigators is that dysmetabolims, via the induction of a chronic inflammatory state could induce a defect of lymphocyte production and activation as well as a modification of the immunogenicity of tumor cells and immune cells infiltration. The consequences could be a decrease in ICI response rate as well as an increase in immune related adverse events (irAEs).
To test this hypothesis, the investigators propose a prospective bi-centric exploratory study including 60 patients treated with ICI for advanced lung or renal cell carcinoma.
The data collected will be :
- Clinical (calorimetry, impedancemetry, survey of eating habits, tumour characteristics, epidemiological data),
- Biologics (baseline and 3-months plasma bio banking for standard biology, inflammation markers TNF- α, IL1-6-8-11-17, TGF-ß, TWEAK, complement study C3, C4, C4d, CH50, C1q, CD46)
Primary objective is to assess the response to ICI depending on metabolic status.
Secondary objectives are to study the relationships between metabolism / cytokines profile/ complement profile and ICI response.
The investigators seek to generate hypotheses and to obtain exploratory data before submission of a Hospital Clinical Research Program whose objective will be to evaluate the impact of dysmetabolism on overall survival and to characterize immune and anatomopathological profiles (using DNA microarrays and flow cytometry techinques) of patients treated with ICI for renal cell or lung carcinoma.
研究概览
地位
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:SIMONAGGIO Audrey, MD
- 电话号码:+33 1 56 09 35 22
- 邮箱:audrey.simonaggio@aphp.fr
研究联系人备份
- 姓名:LE MAO Laura, Msc
- 电话号码:+33 1 56 09 54 97
- 邮箱:laura.le-mao@aphp.fr
学习地点
-
-
Île-de-France
-
Paris、Île-de-France、法国、75014
- 招聘中
- Hôpital Cochin
-
接触:
- Sixtine DE PERCIN
- 电话号码:+33 1 58 41 19 27
- 邮箱:sixtine.depercin@aphp.fr
-
Paris、Île-de-France、法国、75015
- 招聘中
- AP-HP - Hôpital Européen Georges-Pompidou Paris
-
接触:
- Audrey SIMONAGGIO, MD
- 电话号码:+33 1 56 09 35 22
- 邮箱:audrey.simonaggio@aphp.fr
-
-
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
描述
Inclusion Criteria:
- patients ≥18 years
- patients receiving immune checkpoint inhibitors, used alone or as a combination with chemotherapy or tyrosine kinase inhibitor or other immune checkpoint inhibitor, for advanced renal cell or lung carcinoma.
- Patient Informed and signed the consent to participate in the research
Exclusion Criteria:
- patients with history of auto immune disease
- patients enrolled in an interventional study or be in the exclusion period following a previous research, if applicable
- Patient not affiliated to the social security scheme or under AME
- Patient under guardianship or curatorship or under legal protection
- Patient unable or unwilling to give written consent
- Pregnant patient
be in the exclusion period following a previous research, if applicable
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:患者
|
biobanking (30ml) for cytokines and complement dosages at baseline and after 3 months of treatment calorimetry and impedance measure will be collected at baseline and after 3 months of ICI treatment
其他名称:
|
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 |
---|---|---|
response rate according to metabolic status
大体时间:6 months from randomisation
|
response rate after 6 months of ICI treatment (iRECIST criteria)
|
6 months from randomisation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
6 months progression free survival according to metabolic status
大体时间:6 months from randomisation
|
6 months progression free survival according to metabolic status
|
6 months from randomisation
|
12 months overall survival according to metabolic status
大体时间:12months from randomisation
|
12 months overall survival according to metabolic status
|
12months from randomisation
|
correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI
大体时间:12 months from randomisation
|
correlations between metabolism/ cytokines dosage/ complement dosage and
|
12 months from randomisation
|
incidence of irAEs according to metabolic profile
大体时间:6 months from randomisation
|
incidence of irAEs according to metabolic profile
|
6 months from randomisation
|
合作者和调查者
调查人员
- 首席研究员:SIMONAGGIO Audrey, MD、Hopital Europeen Georges-Pompidou
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
其他相关的 MeSH 术语
其他研究编号
- APHP201166
- IDRCB 2020-A02262-37 (其他标识符:ANSM)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.
Data sharing must respect the agreements made with funders.
Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement.
Processing of shared data must comply with European General Data Protection Regulation (GDPR).
IPD 共享支持信息类型
- 研究协议
- 知情同意书 (ICF)
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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