In recent years, immunotherapy has been postulated as one of the most effective strategy in the fight against cancer. The greatest success in this field has been achieved through the inhibition of molecules involved in the brake of the adaptive immune response. The compounds capable of blocking the action of these molecules constitute the "immune checkpoint inhibitors" (ICI). Despite its efficacy, the treatment with ICI causes adverse effects, and in the case of kidney damage, the prognosis has been shown to worsen in cancer patients who develop renal dysfunction. Currently, the diagnosis based on laboratory tests is insufficient to predict the underlying kidney injury and identify the type of damage. The hypothesis proposed that the renal lesion could be subclinical, and therefore the possibility of using new urinary biomarkers could be a useful diagnostic tool that would allow these patients to be managed in a preventive (risk markers) and early way (early markers), and even to elucidate if renal damage is due to this therapy or to other factors (differential diagnostic markers). To develop this hypothesis it is proposed to validate biomarkers in patients treated with ICI by developing a prospective study. The diagnostic products derived from this study will improve the clinical practice of cancer treatment with ICI, and therefore the expectancy and quality of life of patients.
Age range
18 Years – 100 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change of urinary albumin
Timeframe: During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)
Change of urinary N-Acetyl-β-D-Glucosaminidase (NAG)
Timeframe: During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)
Change of urinary Kidney Injury Molecule-1 (KIM-1)
Timeframe: During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)
Change of urinary Neutrophil gelatinase-associated lipocalin (NGAL)
Timeframe: During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)
Change of urinary biomarkers of predisposition to kidney injury
Timeframe: During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)