Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated With Nivolumab (I-Rene Trial)

Study Overview
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Brief Summary
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Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)

Detailed Description
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Prospective translational study investigating predictors of outcome in metastatic renal cell carcinoma patients treated with Nivolumab (I-Rene trial)

Official Title
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Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated With Nivolumab (I-Rene Trial)

Conditions
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Metastatic Renal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent metastatic renal cell carcinoma (a clear-cell/ not clear-cell) Progression to previous treatment with tyrosine kinase inhibitors Patients candidates for II-line therapy with Nivolumab (or tyrosine kinase inhibitors-in the control arm) Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients treated with nivolumab<br>Patients candidates for II line therapy with Nivolumab from clinical practice | |
| patients treated with TKI<br>Patients candidates for II line therapy with TKI from clinical practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the predictive role of circulating miRNAs will be studied with OpenArray technology (OA, Thermo Fisher) | To investigate the predictive role of circulating miRNAs in patients who respond to nivolumab versus those who do not respond before treatment, after two infusions (4 weeks), at the first radiological re-evaluation (12 weeks) and at the time of disease progression. | 36 months | 
| To evaluate whether the immunological profile of tumor tissue or circulating tumor cells Using Multiplexed Biomarker Imaging (MBI), multiparametric flow cytometry | To evaluate whether the immunological profile of tumor tissue or circulating tumor cells may be a potential predictor of clinical response in patients treated with nivolumab. Using Multiplexed Biomarker Imaging (MBI), multiparametric flow cytometry | 36 months | 
| Characterize alterations in genes and signal transmission pathways. Using Next Generation Sequencing, NGS) | o characterize alterations in genes and signaling pathways and to identify mutational burden differences between tumors of patients with metastatic renal cell carcinoma who respond or not to nivolumab. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic renal cell carcinoma, Predictive factors