Clinical trial · Interventional
Circulating and Urinary Exosomal miRNA as Predictors of Treatment Response in Advanced Kidney Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating and Urinary Exosomal miRNA Analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exosomal miRNA Monitoring During Systemic Therapy
- interventionNames
- Diagnostic Test: Circulating and Urinary Exosomal miRNA Analysis
Primary outcomes (3)
- measure
- Change in Circulating Exosomal miRNA Relative Expression (ΔCt) Measured by Quantitative PCR
- timeFrame
- Baseline to Week 16
- description
- 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).
- measure
- Radiological Response Rate Assessed by RECIST 1.1
- timeFrame
- Week 16
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available