Understanding kidney toxicity from Cisplatin in cancer patients
A Canadian Study of Cisplatin mEtabolomics and NephroToxicity
This study is testing how Cisplatin, a common chemotherapy drug, affects kidney health in both adult and child cancer patients to find early signs of kidney damage and improve treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 3 Months and up |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT04442516 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the nephrotoxic effects of Cisplatin, a common chemotherapy drug used for treating various cancers. It will involve adult and pediatric patients initiating Cisplatin treatment, who will provide blood, urine, and saliva samples, along with completing questionnaires. The goal is to identify early biomarkers of acute kidney injury (AKI) to enable preemptive interventions and improve patient outcomes. By understanding the metabolic changes associated with Cisplatin treatment, the study seeks to mitigate the risk of kidney damage.
Who should consider this trial
Good fit: Ideal candidates include adults and children starting treatment with Cisplatin for head, neck, or lung cancers.
Not a fit: Patients with chronic kidney disease or those who have previously received Cisplatin or other nephrotoxic drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early detection and prevention of kidney injury in patients receiving Cisplatin, improving their overall health outcomes.
How similar studies have performed: While the approach of identifying biomarkers for nephrotoxicity is being explored, this specific study's focus on Cisplatin-induced kidney toxicity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult participants: Initiating treatment with CisP (≥75 mg/m2) for head/neck or lung cancers at one of the Adult participating sites; 18 years of age or older. * Paediatric participants: Initiating treatment with CisP for any cancer diagnosis at one of the Pediatric participating sites; greater than 3 months of age. * All participants: Consent to participate in the study. Exclusion Criteria: * Diagnosis of chronic kidney disease (CKD) at baseline (glomerular filtration rate \<60 mL/min/1.73m2, determined by chart review of either formal glomerular filtration rate testing, 24 hour creatinine creatinine clearance of age-appropriate serum creatinine-based estimated glomerular filtration rate equations; past kidney transplant) * Previous use of any nephrotoxic drugs included on the provided Excluded Nephrotoxic Medications list in the two weeks prior to initiation of CisP treatment * Previous use of CisP * Previous radiotherapy (total body irradiation or abdominal radiation only) in the last 1 month prior to study * Previous hematopoietic stem cell transplant * Any chronic or acute health condition that the investigator feels would render the patient inappropriate for this study, including but not limited to significant uncontrolled cardiorespiratory, hepatic, infectious, or renal disease at the discretion of the investigator
Where this trial is running
London, Ontario
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Michael Zappitelli, MD
- Email: michael.zappitelli@sickkids.ca
- Phone: 416-813-7654
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.