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

Institute of Oncology Ljubljana

Status: Completed

Conditions: Advanced Kidney Cancer; Renal Cell Carcinoma

Treatments: Other: Blood and Urine Sampling for Exosomal miRNA Analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT07406646

ERID-KSOPKR-0083/2021 (Other Identifier)

OI-EXO-RENAL1

Details and patient eligibility

About

This prospective cohort study will investigate whether changes in circulating and urinary exosomal biomarkers (target exosomal miRNA) are associated with response to systemic treatment in patients with advanced renal cell carcinoma. Patients treated with immune checkpoint inhibitors or targeted therapies in the first-line or second-line setting will be included. Exosomal biomarker expression will be analyzed in blood and urine samples collected during the first 16 weeks of treatment. Treatment response will be assessed using standard radiological imaging. The study aims to determine whether changes in exosomal miRNA expression after treatment initiation can serve as predictive biomarkers of objective response in advanced kidney cancer.

Full description

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

EXO-RENAL1 Cohort

Other group

Description:

Patients with advanced renal cell carcinoma receiving standard-of-care systemic treatment (immune checkpoint inhibitors or targeted therapy) in the first-line or second-line setting. Circulating and urinary exosomal miRNA will be monitored during the first 16 weeks of treatment using blood and urine samples.

Treatment:

Other: Blood and Urine Sampling for Exosomal miRNA Analysis