Circulating and Urinary Exosomal miRNA as Predictors of Treatment Response in Advanced Kidney Cancer (EXO-RENAL2)

February 20, 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 (EXO-RENAL2)

This study investigates the role of circulating and urinary exosomal microRNAs (miRNAs) as potential biomarkers for predicting response to systemic therapy in patients with advanced renal cell carcinoma. Patients receiving immune checkpoint inhibitors or targeted therapies are followed during the first 16 weeks of treatment. Blood and urine samples are collected at predefined time points for analysis of exosome-associated miRNAs. Imaging assessments are performed as part of routine clinical follow-up. The aim of the study is to identify exosomal miRNA profiles associated with treatment response and to support the development of non-invasive predictive biomarkers in advanced kidney cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Advanced renal cell carcinoma is commonly treated with immune checkpoint inhibitors and targeted therapies; however, patient response is heterogeneous and reliable predictive biomarkers are limited. Exosomes are extracellular vesicles released by cells into body fluids and contain molecular cargo such as microRNAs (miRNAs), which may reflect tumor biology and immune response. Circulating and urinary exosomal miRNAs represent promising non-invasive biomarkers that could support early prediction of treatment response.

This prospective clinical study evaluates changes in the expression of selected exosome-associated miRNAs in blood and urine and their association with response to systemic therapy in patients with advanced renal cell carcinoma. Eligible participants include patients treated in the first- or second-line setting with immune checkpoint inhibitors or targeted agents. Participants provide blood samples (approximately 10 mL) at four predefined time points and urine samples (approximately 50 mL) at two predefined time points during the first 16 weeks of therapy. Samples are processed according to a standardized protocol including centrifugation and storage at low temperature until further analysis.

Laboratory procedures include isolation of extracellular vesicles from plasma and urine, quantification of extracellular vesicles using nanoparticle tracking analysis, and isolation of exosome-associated miRNA followed by quantitative PCR (qPCR) for selected target miRNAs. Quality assessment of samples is performed, including evaluation of hemolysis and additional purity controls.

Clinical data and radiological imaging results collected during routine clinical management are used to assess treatment response. The primary objective is to identify associations between exosomal miRNA expression patterns and treatment response during early therapy. The study aims to contribute to the development of minimally invasive biomarkers for prediction of therapy response in advanced kidney cancer and to improve patient stratification for systemic treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (≥18 years)
  • Histologically confirmed advanced or metastatic renal cell carcinoma
  • Receiving systemic treatment with immune checkpoint inhibitors and/or targeted therapy (first- or second-line therapy)
  • Ability to provide blood and urine samples according to the study protocol
  • Written informed consent

Exclusion Criteria:

  • Age <18 years
  • Inability to provide required blood and urine samples
  • Inability to provide informed consent
  • Any condition preventing participation according to investigator assessment

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exosomal miRNA Monitoring During Systemic Therapy
Diagnostic test: Circulating and Urinary Exosomal miRNA Analysis
Blood and urine samples are collected at predefined time points during the first 16 weeks of systemic therapy. Exosomes (extracellular vesicles) are isolated from plasma and urine, quantified, and exosome-associated microRNAs are extracted and analyzed using quantitative PCR (qPCR). The intervention is performed to evaluate exosomal miRNA profiles as predictive biomarkers of treatment response in advanced renal cell carcinoma.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Circulating Exosomal miRNA Relative Expression (ΔCt) Measured by Quantitative PCR
Time Frame: Baseline to Week 16
Change from baseline to Week 16 in selected circulating exosome-associated microRNA expression levels measured in plasma using quantitative polymerase chain reaction (qPCR). Expression is quantified as relative cycle threshold values (ΔCt).
Baseline to Week 16
Radiological Response Rate Assessed by RECIST 1.1
Time Frame: Week 16
Radiological treatment response at Week 16 assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Response categories include Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). Outcome reported as proportion of patients in each response category.
Week 16
Spearman Correlation Coefficient Between Change in Circulating Exosomal miRNA Expression (ΔCt) and Radiological Response (RECIST 1.1)
Time Frame: Week 16
Spearman correlation coefficient (rho) between change from baseline to Week 16 in circulating exosomal miRNA relative expression levels (ΔCt, measured by qPCR) and radiological treatment response at Week 16 assessed using RECIST version 1.1.
Week 16

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OI-EXO-RENAL2-2022
  • 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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