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

February 5, 2026 updated by: Institute of Oncology Ljubljana

The Role of Monitoring of the Circulating and Urinary Exosomal miRNA for Prediction of Response to Treatment in Patients With Advanced Kidney Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EXO-RENAL1 Cohort
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.
Other: Blood and Urine Sampling for Exosomal miRNA Analysis
Collection of peripheral blood and urine samples for analysis of circulating and urinary exosomal miRNA during the first 16 weeks of systemic treatment in patients with advanced renal cell carcinoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Plasma Exosomal miRNA Expression and Objective Response
Time Frame: During the first 16 weeks of treatment
To determine whether changes in the expression of target plasma exosomal miRNA after initiation of systemic treatment are associated with objective response to treatment in patients with advanced renal cell carcinoma receiving immune checkpoint inhibitors or targeted therapy.
During the first 16 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Urinary Exosomal miRNA Expression and Objective Response
Time Frame: During the first 16 weeks of treatment
To determine whether changes in the expression of target urinary exosomal miRNA after initiation of systemic treatment are associated with objective response to treatment in patients with advanced renal cell carcinoma.
During the first 16 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2021

Primary Completion (Actual)

February 17, 2022

Study Completion (Actual)

February 17, 2022

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OI-EXO-RENAL1
  • ERID-KSOPKR-0083/2021 (Other Identifier: Commission for the Professional Evaluation of Clinical Research Protocols (KSOPKR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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