A Canadian Study of Cisplatin mEtabolomics and NephroToxicity

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
Contact Information
Primary
Michael Zappitelli, MD
michael.zappitelli@sickkids.ca
416-813-7654
Backup
Jasmine Lee, MSc
jasmine.lee@sickkids.ca
416-813-7654
Time Frame
Start Date: 2020-08-12
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 600
Treatments
Adults receiving Cisplatin as part of their cancer therapy
Children receiving Cisplatin as part of their cancer therapy
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), London Health Sciences Centre, Provincial Health Services Authority
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov