RecruitingNCT04902846

Immune Checkpoint Inhibitors Nephrotoxicity

Application of Biomarkers of Renal Damage in Patients Treated With Immune Checkpoint Inhibitors


Sponsor

R. Laura Vicente Vicente

Enrollment

220 participants

Start Date

May 19, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria1

  • Patients waiting for immunotherapy or combination immunotherapy / platinum compounds

Exclusion Criteria2

  • Patients who are terminally ill
  • Patients who do not wish to sign the informed consent

Interventions

DIAGNOSTIC_TESTEarly kidney damage biomarkers

In the urine samples of these patients, a series of biomarkers of early kidney damage and / or predisposition to kidney damage will be measured.

DIAGNOSTIC_TESTPredisposition to kidney injury biomarkers

In the urine samples of these patients, a series of biomarkers of predisposition to kidney damage will be measured.


Locations(2)

Servicio de Oncología del CAUSA

Salamanca, Spain

Servicio de oncología del Hospital Universitario de Valladolid

Valladolid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04902846


Related Trials