About this trial
Background: Childhood cancer survivors (CCS) are at elevated risk of chronic health conditions. Chemotherapies can cause recurrent acute kidney injury which may progress to kidney fibrosis, chronic kidney disease (CKD) or hypertension (HTN). CCS surviving to adulthood are at ≥3 times the risk (vs. non-CCS) for CKD, HTN and lower quality of life. However, the timing of CKD and HTN onset in CCS completing cancer therapy in childhood remains unclear.
Guidelines provide recommendations on managing post-cancer therapy effects in CCS, but they lack specificity on kidney testing content, frequency and complications. This discord is largely due to knowledge gaps on which CCS develop CKD or HTN after cancer therapy, when outcomes occur and their severity. Existing work has shown in select patients, CKD and HTN in CCS likely begins in the first 5 years post-cancer therapy and that the burden is significant. With robust data on CKD and HTN, international CCS follow-up guidelines can be optimized to include detailed and actionable recommendations on kidney and blood pressure monitoring and treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
3 years ± 6 months after therapy for first cancer
Received high-risk therapy for first cancer, as defined by the Canadian Oncology Group (COG) as alkylating agents; platinums; abdominal or total body radiation; high dose methotrexate; stem cell transplant; nephrectomy; or other therapy which may be known to possibly cause late kidney and/or BP effects.
Disqualifiers
Pre-cancer severe CKD and/or previous kidney transplant
>19 years old at 3 years after cancer therapy completion
Trial population
Observational cohort study of CCS at 5 Ontario child cancer centres
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prevalence of Chronic Kidney Disease (CKD) based on eGFR (using an equation) at 3 years post cancer therapy
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Prevalence of Chronic Kidney Disease (CKD) based on eGFR (using an equation) at 5 years post cancer therapy
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Prevalence of Hypertension (HTN) from office blood pressure (vis blood pressure machine) at 3 years post cancer therapy
Defined by 2017 American Academy of Pediatrics (AAP) guidelines
Prevalence of Hypertension (HTN) using Ambulatory Blood Pressure Measurement (ABPM) at 5 years post cancer therapy
The presence of either ambulatory hypertension or masked hypertension
Secondary outcomes
Impact of Acute Kidney Injury (AKI) and Cardiometabolic risk factors (using blood work) at baseline on CKD outcomes
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Sponsors and contacts
Click on the lead sponsor to view all of their trials.