Investigating kidney damage from immune checkpoint inhibitors
Application of Biomarkers of Renal Damage in Patients Treated With Immune Checkpoint Inhibitors
This study is testing how immune checkpoint inhibitors used in cancer treatment might affect kidney health in patients starting immunotherapy, to find ways to spot problems early.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 2 sites (Salamanca and 1 other locations) |
| Trial ID | NCT04902846 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the nephrotoxicity associated with immune checkpoint inhibitors (ICIs) used in cancer treatment. It focuses on identifying early and predisposition biomarkers for kidney injury in patients undergoing immunotherapy or combination therapies. By understanding the subclinical renal lesions that may arise, the study seeks to enhance patient management through preventive and early diagnostic strategies. The research will involve patients who are about to start immunotherapy, assessing their kidney function and potential risks.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who are about to begin immunotherapy or combination therapies involving platinum compounds.
Not a fit: Patients who are terminally ill or unwilling to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of kidney health in cancer patients receiving immunotherapy.
How similar studies have performed: While nephrotoxicity in cancer treatments is a known issue, the specific use of urinary biomarkers for early detection in the context of ICIs is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients waiting for immunotherapy or combination immunotherapy / platinum compounds Exclusion Criteria: * Patients who are terminally ill * Patients who do not wish to sign the informed consent
Where this trial is running
Salamanca and 1 other locations
- Servicio de Oncología del CAUSA — Salamanca, Spain (Recruiting)
- Servicio de oncología del Hospital Universitario de Valladolid — Valladolid, Spain (Recruiting)
Study contacts
- Principal investigator: Ana Isabel Morales Martín, PhD — University of Salamanca
- Study coordinator: Ana Isabel Morales Martín, PhD
- Email: amorales@usal.es
- Phone: +34923294400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.