NCT04902846 Immune Checkpoint Inhibitors Nephrotoxicity
| NCT ID | NCT04902846 |
| Status | Recruiting |
| Phase | — |
| Sponsor | R. Laura Vicente Vicente |
| Condition | Kidney Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2021-05-19 |
| Primary Completion | 2028-04-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 220 participants in total. It began in 2021-05-19 with a primary completion date of 2028-04-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Ana Isabel Morales Martín, PhD
PRINCIPAL INVESTIGATOR
University of Salamanca
Frequently Asked Questions
Who can join the NCT04902846 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04902846 currently recruiting?
Yes, NCT04902846 is actively recruiting participants. Contact the research team at amorales@usal.es for enrollment information.
Where is the NCT04902846 trial being conducted?
This trial is being conducted at Salamanca, Spain, Valladolid, Spain.
Who is sponsoring the NCT04902846 clinical trial?
NCT04902846 is sponsored by R. Laura Vicente Vicente. The principal investigator is Ana Isabel Morales Martín, PhD at University of Salamanca. The trial plans to enroll 220 participants.
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