Immune Checkpoint Inhibitors Nephrotoxicity
Recruiting now
Conditions studied: Kidney Injury, Antineoplastics Toxicity
In brief
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.
Key facts
- Study ID
- NCT04902846
- Run by
- R. Laura Vicente Vicente
- People needed
- 220
- Starts
- 2021-05-19
- Expected to finish
- 2030-12-30
- Last updated by the study team
- 2025-02-26
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients waiting for immunotherapy or combination immunotherapy / platinum compounds
You may not qualify if…
- Patients who are terminally ill
- Patients who do not wish to sign the informed consent
Where it is running
- Servicio de Oncología del CAUSA — Salamanca, Spain (enrolling)
- Servicio de oncología del Hospital Universitario de Valladolid — Valladolid, Spain (enrolling)
Full record on ClinicalTrials.gov
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