Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT04902846

Immune Checkpoint Inhibitors Nephrotoxicity

Led by R. Laura Vicente Vicente · Updated on 2025-02-26

220

Participants Needed

2

Research Sites

501 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

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.

CONDITIONS

Official Title

Immune Checkpoint Inhibitors Nephrotoxicity

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients waiting for immunotherapy or combination immunotherapy / platinum compounds
Not Eligible

You will not qualify if you...

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

AI-Screening

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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

CONTACT

L

Laura Vicente Vicente, PhD

CONTACT

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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