Advanced Kidney Cancer, Renal Cell Carcinoma
Conditions
Keywords
Exosomal miRNA, Circulating Biomarkers
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.
Detailed description
This is a prospective observational cohort study conducted at the Institute of Oncology Ljubljana. The study will evaluate the predictive value of circulating and urinary exosomal biomarkers (target exosomal miRNA) for response to systemic therapy in patients with advanced renal cell carcinoma. Patients receiving immune checkpoint inhibitors or targeted therapy in the first-line or second-line treatment setting will be enrolled. The primary objective is to determine whether changes in the expression of selected exosomal miRNA in plasma after initiation of systemic treatment are associated with objective response to therapy. In addition, urinary exosomal miRNA will be evaluated as a potential predictive biomarker. Blood and urine samples will be collected during the first 16 weeks of treatment. Each participant will provide four peripheral blood samples (10 mL each) and two urine samples (50 mL each). Radiological imaging will be performed as part of routine clinical follow-up to assess treatment response. The association between changes in exosomal miRNA expression and treatment outcomes will be analyzed.
Interventions
OTHERBlood and Urine Sampling for Exosomal miRNA Analysis
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.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma Exosomal miRNA Expression and Objective Response | During the first 16 weeks of treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Exosomal miRNA Expression and Objective Response | During the first 16 weeks of treatment | To determine whether changes in the expression of target urinary exosomal miRNA after initiation of systemic treatment are associated with objective response to treatment in patients with advanced renal cell carcinoma. |
Countries
Slovenia
Outcome results
None listed