Clinical trial NCT04891055: Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated With Nivolumab (I-Rene Trial)
Official title: Prospective Translational Study Investigating Predictors of Outcome in Metastatic Renal Cell Carcinoma Patients Treated With Nivolumab (I-Rene Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Metastatic renal cell carcinoma
Predictive factors
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
Collaborators: name: Ministero della Salute, Italy
First posted: 2021-05-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: metastatic renal cell carcinoma

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Investigate the predictive role of circulating miRNAs will be studied with OpenArray technology (OA, Thermo Fisher)
timeFrame: 36 months
measure: To evaluate whether the immunological profile of tumor tissue or circulating tumor cells Using Multiplexed Biomarker Imaging (MBI), multiparametric flow cytometry
timeFrame: 36 months
measure: Characterize alterations in genes and signal transmission pathways. Using Next Generation Sequencing, NGS)
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale Tumori Milano
name: Giuseppe Procopio, MD
role: PRINCIPAL_INVESTIGATOR
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