NCT07436416

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

February 12, 2026

Last Update Submit

February 20, 2026

Conditions

Renal Cell Carcinoma

Keywords

Extracellular vesiclesLiquid biopsy

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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.

    Week 16

Study Arms (1)

Exosomal miRNA Monitoring During Systemic Therapy

EXPERIMENTAL
Diagnostic Test: Circulating and Urinary Exosomal miRNA Analysis

Interventions

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.

Exosomal miRNA Monitoring During Systemic Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 27, 2026

Study Start

March 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)