Circulating and Urinary Exosomal miRNA in Advanced Kidney Cancer (EXO-RENAL1)

NCT07406646 | Completed

• 2 other identifiers: OI-EXO-RENAL1ERID-KSOPKR-0083/2021
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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

Renal Cell Carcinoma; Advanced Kidney Cancer

Keywords

Exosomal miRNA; Circulating Biomarkers

Outcome Measures

Primary Outcomes (1)

• Change in Plasma Exosomal miRNA Expression and Objective Response

  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.

  During the first 16 weeks of treatment

Secondary Outcomes (1)

• Change in Urinary Exosomal miRNA Expression and Objective Response

  During the first 16 weeks of treatment

Study Arms (1)

EXO-RENAL1 Cohort

OTHER

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.

Other: Blood and Urine Sampling for Exosomal miRNA Analysis

Interventions

Blood and Urine Sampling for Exosomal miRNA Analysis OTHER

Collection of peripheral blood and urine samples for analysis of circulating and urinary exosomal miRNA during the first 16 weeks of systemic treatment in patients with advanced renal cell carcinoma.

EXO-RENAL1 Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

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 5, 2026
• First Posted: February 12, 2026
• Study Start: November 2, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)