Renal Cell CarcinomaEXO-RENAL2NCT07436416
Circulating and Urinary Exosomal miRNA as Predictors of Treatment Response in Advanced Kidney Cancer
A study testing Circulating and Urinary Exosomal miRNA Analysis in people with Renal Cell Carcinoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Circulating and Urinary Exosomal miRNA Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Inability to provide required blood and urine samples
- Inability to provide informed consent
- Any condition preventing participation according to investigator assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Circulating and Urinary Exosomal miRNA Analysis
- Keywords
- Extracellular vesicles, Liquid biopsy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating and Urinary Exosomal miRNA AnalysisDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Exosomal miRNA Monitoring During Systemic Therapy | Experimental | Not described Receives: Diagnostic Test: Circulating and Urinary Exosomal miRNA Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Circulating Exosomal miRNA Relative Expression (ΔCt) Measured by Quantitative PCR
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).
Measured: Baseline to Week 16
Radiological Response Rate Assessed by RECIST 1.1
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.
Measured: Week 16
Spearman Correlation Coefficient Between Change in Circulating Exosomal miRNA Expression (ΔCt) and Radiological Response (RECIST 1.1)
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.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436416
- Sponsor's protocol ID
- OI-EXO-RENAL2-2022
- Other IDs
- ERID-KSOPKR-0083/2021
- Acronym
- EXO-RENAL2
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07436416
- Acronym / sponsor ID
- EXO-RENAL2 / OI-EXO-RENAL2-2022
- Conditions
- Renal Cell Carcinoma
- Keywords
- Extracellular vesicles, Liquid biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exosomal miRNA Monitoring During Systemic Therapy | Experimental | Diagnostic Test: Circulating and Urinary Exosomal miRNA Analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Age <18 years
- Inability to provide required blood and urine samples
- Inability to provide informed consent
- Any condition preventing participation according to investigator assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating and Urinary Exosomal miRNA AnalysisBlood 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. | Diagnostic test | Exosomal miRNA Monitoring During Systemic Therapy |
Primary outcome
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circulating and Urinary Exosomal miRNA Analysis in people with Renal Cell Carcinoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Circulating Exosomal miRNA Relative Expression (ΔCt) Measured by Quantitative PCR (time frame: Baseline to Week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.