Circulating and Urinary Exosomal miRNA in Advanced Kidney Cancer (EXO-RENAL1)

This is a prospective observational cohort study conducted at the Institute of Oncology Ljubljana. The study will evaluate the predictive value of circulating and urinary exosomal biomarkers (target exosomal miRNA) for response to systemic therapy in patients with advanced renal cell carcinoma.

Patients receiving immune checkpoint inhibitors or targeted therapy in the first-line or second-line treatment setting will be enrolled. The primary objective is to determine whether changes in the expression of selected exosomal miRNA in plasma after initiation of systemic treatment are associated with objective response to therapy. In addition, urinary exosomal miRNA will be evaluated as a potential predictive biomarker.

Blood and urine samples will be collected during the first 16 weeks of treatment. Each participant will provide four peripheral blood samples (10 mL each) and two urine samples (50 mL each). Radiological imaging will be performed as part of routine clinical follow-up to assess treatment response. The association between changes in exosomal miRNA expression and treatment outcomes will be analyzed.

Inclusion criteria

Adult patients (≥ 18 years).

Histologically confirmed advanced renal cell carcinoma.

Patients receiving systemic treatment with immune checkpoint inhibitors or targeted therapy in the first-line or second-line setting.

Ability to provide blood and urine samples according to the study protocol.

Signed informed consent.

Exclusion criteria

Patients unable to provide required biological samples.

Patients with missing clinical or imaging data required for treatment response assessment.

Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation.