此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Relationship Between Immunity and Metabolism in Patients Receiving Immune Checkpoint Inhibitors for Advanced Cancer. ( RIMEC ) (RIMEC)

2021年11月15日 更新者:Assistance Publique - Hôpitaux de Paris

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

研究类型

介入性

注册 (预期的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Île-de-France
      • Paris、Île-de-France、法国、75014
        • 招聘中
        • Hôpital Cochin
        • 接触:
      • Paris、Île-de-France、法国、75015
        • 招聘中
        • AP-HP - Hôpital Européen Georges-Pompidou Paris
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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:
  • biobanking (30ml)

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

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:SIMONAGGIO Audrey, MD、Hopital Europeen Georges-Pompidou

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年5月10日

初级完成 (预期的)

2023年11月1日

研究完成 (预期的)

2024年5月1日

研究注册日期

首次提交

2021年3月8日

首先提交符合 QC 标准的

2021年3月19日

首次发布 (实际的)

2021年3月22日

研究记录更新

最后更新发布 (实际的)

2021年11月19日

上次提交的符合 QC 标准的更新

2021年11月15日

最后验证

2021年11月1日

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)?

是的

IPD 计划说明

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD 共享时间框架

Two years after the last publication

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

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅