NCT04902846

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
May 2021Dec 2030

First Submitted

Initial submission to the registry

May 19, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2028

Expected
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

6.9 years

First QC Date

May 19, 2021

Last Update Submit

February 25, 2025

Conditions

Kidney InjuryAntineoplastics Toxicity

Keywords

DiagnosisNephrotoxicityPreventionOncologyImmune check point inhibitors

Outcome Measures

Primary Outcomes (5)

  • Change of urinary albumin

    It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

    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)

    It is an enzyme whose urinary excretion is elevated in case of kidney damage. It is capable of detecting damage before the classic plasma creatinin and urea markers. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

    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)

    It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

    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)

    It is a biomarker of early kidney damage. It is able to detect kidney damage in the early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

    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

    It is a group of markers that are in patent phase so their names can not be mentioned. They are able to detect the susceptibility to kidney damage before administering a nephrotoxic agent. There are no reference values for humans, so the means of non-smoking patients without risk factors (group 1) should be compared with the rest of the groups. This biomarker will be measured at different times to evaluate its evolution and compare it against the baseline value.

    During 1 year at the times: pre ICI (before administering each cycle of ICI) and post ICI (one week after each administration of ICI)

Secondary Outcomes (6)

  • Body weight

    These data will be collected once, at time 0 (moment of enrollment in the study)

  • Height

    These data will be collected once, at time 0 (moment of enrollment in the study)

  • Body mass index (BMI)

    These data will be collected once, at time 0 (moment of enrollment in the study)

  • Age

    These data will be collected once, at time 0 (moment of enrollment in the study)

  • Gender

    These data will be collected once, at time 0 (moment of enrollment in the study)

  • +1 more secondary outcomes

Study Arms (2)

Control (no kidney injury)

Patients who receive ICI but no develop kidney injury

Diagnostic Test: Early kidney damage biomarkersDiagnostic Test: Predisposition to kidney injury biomarkers

Case (kidney injury)

Patients who receive ICI and develop kidney injury

Diagnostic Test: Early kidney damage biomarkersDiagnostic Test: Predisposition to kidney injury biomarkers

Interventions

Early kidney damage biomarkersDIAGNOSTIC_TEST

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

Also known as: albumin, N-acetyl-beta-D-glucosaminidase (NAG), Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL)
Case (kidney injury)Control (no kidney injury)
Predisposition to kidney injury biomarkersDIAGNOSTIC_TEST

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

Also known as: Transferrin, Ganglioside GM2 activator isoform 1 (GM2AP)
Case (kidney injury)Control (no kidney injury)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who will receive ICI as part of a diagnostic or interventional procedure

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Servicio de Oncología del CAUSA

Salamanca, Spain

RECRUITING

Servicio de oncología del Hospital Universitario de Valladolid

Valladolid, Spain

RECRUITING

Related Publications (1)

  • Vicente-Vicente L, Casanova AG, Tascon J, Prieto M, Morales AI. New Challenges in the Diagnosis of Kidney Damage Due to Immune Checkpoint Inhibitors Therapy: An Observational Clinical Study. Diagnostics (Basel). 2023 Jul 28;13(15):2524. doi: 10.3390/diagnostics13152524.

    PMID: 37568887DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

In this project, only urine samples will be collected. This will be centrifuged, aliquoted and stored at -80 degrees Celsius until its determination

MeSH Terms

Conditions

DiseaseNeoplasms

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ana Isabel Morales Martín, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Isabel Morales Martín, PhD

CONTACT

+34923294400amorales@usal.es

Laura Vicente Vicente, PhD

CONTACT

+34923294400lauravicente@usal.es

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
University professor

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 26, 2021

Study Start

May 19, 2021

Primary Completion (Estimated)

April 23, 2028

Study Completion (Estimated)

December 30, 2030

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)