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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2020-A02262-37 | Other Identifier | ANSM |
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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calorimetry, impedance measurement at baseline and after 3 months of treatment | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| response rate according to metabolic status | response rate after 6 months of ICI treatment (iRECIST criteria) | 6 months from randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| 6 months progression free survival according to metabolic status | 6 months progression free survival according to metabolic status | 6 months from randomisation |
| 12 months overall survival according to metabolic status |
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Inclusion Criteria:
Exclusion Criteria:
be in the exclusion period following a previous research, if applicable
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| Name | Affiliation | Role |
|---|---|---|
| SIMONAGGIO Audrey, MD | Hopital europeen Georges-Pompidou | Principal Investigator |
| Charles Vauchier | Hopital europeen Georges-Pompidou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Paris | Île-de-France Region | 75014 | France | ||
| AP-HP - Hôpital Européen Georges-Pompidou Paris |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
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).
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|
|
12 months overall survival according to metabolic status
| 12months from randomisation |
| correlations between metabolism/ cytokines dosage/ complement dosage and response to ICI | correlations between metabolism/ cytokines dosage/ complement dosage and | 12 months from randomisation |
| incidence of irAEs according to metabolic profile | incidence of irAEs according to metabolic profile | 6 months from randomisation |
| Paris |
| Île-de-France Region |
| 75015 |
| France |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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