Studying Kidney Injury Risk in People Receiving Cisplatin Chemotherapy
Studies blood and urine samples to find early signs of kidney injury from cisplatin.
Key facts
- Who runs it
- The Hospital for Sick Children
- Where
- London, CanadaSee the site
- Trial code
- Registry title
- Cisplatin Induced Kidney Toxicity
- Status
- Recruiting
- People taking part
- 600 people, planned
- Started
- 12 Aug 2020
- Expected to end
- 31 Dec 2028
- Type of study
- Observational, 2 groups
- Treatments tested
- Questionnaire, sampling of blood, urine and saliva
- Record updated
- 17 April 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults and children who are about to start cisplatin chemotherapy for cancer. It studies blood and urine markers of kidney injury caused by cisplatin.
- Age
- Adults 18 years or older; children older than 3 months.
- Sex
- All sexes can join.
- Disease stage
- Adults: head and neck or lung cancer. Children: any cancer diagnosis.
- Earlier treatment
- Cisplatin is started at the trial site (adults: at least 75 mg/m2). Must not have had cisplatin before.
Main reasons for not taking part
- Chronic kidney disease at the start (including a past kidney transplant)
- Kidney-harming drugs on the trial's list in the 2 weeks before cisplatin
- Previous cisplatin
- Total body or abdominal radiotherapy in the last 1 month
- Previous stem-cell transplant
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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)
Where in Canada
- London Health Sciences CentreLondon, CanadaContact: Kathie Baer, MScTaking people
About the trial
What the trial wants to find out
Cisplatin (CisP) is a chemotherapeutic agent used to treat head and neck and lung cancer in adults and over 15 different pediatric cancers. Despite its known toxicity, CisP is still widely used as a first line chemotherapy as it is so effective. Nephrotoxicity is one of the most common adverse effects of CisP, occurring in 20-50% of patients. It manifests as acute kidney injury (AKI) typically within the first few days of exposure and is associated with short and long-term morbidity. Furthermore, AKI diagnosis is only possible once kidney damage has progressed to functional impairment, when mitigation strategies are ineffective. Tests that could predict AKI risk pre-emptively or diagnose early-stage AKI before functional loss would be very impactful, affording opportunities for prevention or early intervention to mitigate CisP nephrotoxicity, reduce morbidity and improve health outcomes.
Read full original descriptionShow less
The field of metabolomics seeks to identify patterns of small molecules (metabolites) involved in cell or tissue metabolism related to disease states, or patient factors like lifestyle and genetics. Plasma and urine are ideal for sampling the metabolome, which can identify at-risk patients and reveal disease-related changes earlier than existing diagnostic methods do.
In CisP-treated children and adults from across Canada, we will identify urine and plasma metabolite profiles a) prior to CisP dosing that predict CisP AKI risk, and b) shortly after dosing to identify early-stage nephrotoxicity, before clinical signs of AKI are detectable. Our identified biomarkers will allow individualization of CisP treatment based on the level of nephrotoxicity risk and the design of trials to mitigate the progression and complications of CisP nephrotoxicity.
The 2 groups in the trial
- Adults receiving Cisplatin as part of their cancer therapy
Treatment: Questionnaire, sampling of blood, urine and saliva
- Children receiving Cisplatin as part of their cancer therapy
Treatment: Questionnaire, sampling of blood, urine and saliva
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Canadian Study of Cisplatin mEtabolomics and NephroToxicity
- Plain-language title
- Studying Kidney Injury Risk in People Receiving Cisplatin ChemotherapyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 17 April 2024