New Challenges in the Diagnosis of Kidney Damage Due to Immune Checkpoint Inhibitors Therapy: An Observational Clinical Study.
Laura Vicente-Vicente, Alfredo G Casanova, Javier Tascón...
https://pubmed.ncbi.nlm.nih.gov/37568887Actively Recruiting
Age: 18Years - 100Years
All Genders
ID04902846
Application of Biomarkers of Renal Damage in Patients Treated With Immune Checkpoint Inhibitors
Led by R. Laura Vicente Vicente · Updated on 2025-02-26
220
Participants Needed
2
Research Sites
140 weeks
Total Duration
On this page
Sponsors
R
R. Laura Vicente Vicente
Lead Sponsor
I
Instituto de Investigación Biomédica de Salamanca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring immune checkpoint inhibitors (ICI) as a treatment for cancer, focusing on their impact on kidney health. While ICIs have advanced cancer treatment by blocking molecules that suppress the immune response, they can cause side effects including kidney damage, which worsens the outlook for patients. Diagnosing kidney injury from ICI is challenging because current lab tests detect damage only after it has progressed, and kidney biopsies, though informative, are invasive. This study involves measuring specific urinary biomarkers before and after each immunotherapy cycle over one year to detect early or risk signs of kidney damage in cancer patients treated with ICIs. These biomarkers aim to identify subclinical damage and differentiate kidney injury caused by ICIs from other causes. Urine samples are collected before each treatment cycle and one week afterward, with analyses conducted in specialized labs to evaluate kidney function and injury markers. Participants provide their health and treatment history, and their kidney function is monitored using blood and urine tests. The study tracks changes in multiple urinary biomarkers over time to better predict and manage kidney injury during immunotherapy. Data analysis will use various statistical methods to validate these biomarkers as diagnostic tools, potentially improving patient care by enabling earlier detection and personalized treatment adjustments.
CONDITIONS
Brief Title
Immune Checkpoint Inhibitors Nephrotoxicity
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients waiting for immunotherapy or combination immunotherapy / platinum compounds
- Age between 18 and 100 years
You will not qualify if you...
- Patients who are terminally ill
- Patients who do not wish to sign the informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 1 year
Participants provide urine samples before each antineoplastic cycle and one week after each cycle to measure biomarkers of early kidney damage and predisposition to kidney injury. Clinical data including plasma creatinine, urea, and electrolytes levels are collected throughout the study.
Visits before and one week after each treatment cycle during the study period
Trial Site Locations
Total: 2 locations
1
Servicio de Oncología del CAUSA
Salamanca, Spain
Actively Recruiting
2
Servicio de oncología del Hospital Universitario de Valladolid
Valladolid, Spain
Actively Recruiting
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Research Team
A
Ana Isabel Morales Martín, PhD
L
Laura Vicente Vicente, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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