Clinical trial · Interventional
Circulating and Urinary Exosomal miRNA in Advanced Kidney Cancer (EXO-RENAL1)
The Role of Monitoring of the Circulating and Urinary Exosomal miRNA for Prediction of Response to Treatment in Patients With Advanced Kidney Cancer
- 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 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Kidney Cancer | Malignant Kidney Neoplasm | CURATED_BROADER | 0.78 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood and Urine Sampling for Exosomal miRNA Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- EXO-RENAL1 Cohort
- 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.
- interventionNames
- Other: Blood and Urine Sampling for Exosomal miRNA Analysis
Primary outcomes (1)
- measure
- Change in Plasma Exosomal miRNA Expression and Objective Response
- timeFrame
- During the first 16 weeks of treatment
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available