The Hospital For Sick Children
Toronto, Ontario, M5G 1E8, Canada
Location status: Recruiting
NCT Number: NCT06153147
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.
Interested in participating?
Request InfoUp to 19 year
All sexes
Observational
Toronto, Ontario, M5G 1E8, Canada
Location status: Recruiting
Significant improvements in childhood cancer survival rates have come at the cost of an increase in chronic health conditions. Childhood cancer survivors (CCS) often experience chronic kidney disease (CKD) and hypertension (HTN), yet data on the onset and severity of these diseases in the primary years after childhood cancer therapy is unclear. Both CKD and HTN are major treatable cardiovascular risk factors, and the knowledge gap in the first 5 years after therapy impedes the creation of evidence-based guidelines and early intervention plans.
Currently, the Children's Oncology Group international guidelines, which are used to identify and manage therapy effects in CCS, lack information on CKD testing and appropriate measures. With appropriate treatment, CKD and HTN complications are treatable.
In 500 CCS at high risk for blood pressure (BP) and late kidney effects due to cancer therapy, we will determine the prevalence of HTN and CKD at 3 and 5 years after cancer therapy, and the extent to which eGFR, albuminuria and BP worsen from 3 to 5 years after therapy. In addition, we will assess whether acute kidney injury during cancer therapy and cardiometabolic risk factors are associated with these outcomes.
Based on the evidence from the study, we hope to improve current CCS kidney and BP guidelines to advise on appropriate treatments and measures for HTN and CKD. As CCS are vulnerable to cardiovascular disease, addressing CKD and HTN complications will improve their overall quality of life.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 years +/- 6 months after cancer therapy end
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Time frame: 5 years +/- 6 months after cancer therapy end
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Time frame: 3 years +/- 6 months after cancer therapy end
Defined by 2017 American Academy of Pediatrics (AAP) guidelines
Time frame: 5 years +/- 6 months after cancer therapy end
The presence of either ambulatory hypertension or masked hypertension
Time frame: Change from 3 to 5 years in eGFR
Change in eGFR in milliliter (mL) /min/1.73m2
Time frame: Change from 3 to 5 years in Albuminuria
Change in albuminuria in mg/g
Time frame: Change from 3 to 5 years in Proteinuria
Change in proteinuria in mg/mmol
Time frame: Change from 3 to 5 years
Change in BP percentile as per 2017 American Academy of Pediatrics (AAP) guidelines
Time frame: At baseline for independent factors on CKD outcomes at 3 and 5 years
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Contact information is provided by the study sponsor or research team.
Michael Zappitelli, MD
CONTACT
4168137605 ext. 304077
Yasmine Hejri-Rad, BA
CONTACT
416-813-7605 ext. 309031
The Hospital for Sick Children
Other
KIdney aNd blooD prESsure ouTcomes in Childhood Cancer Survivors (CCS): Prospective Study
Acronym: KINDEST-CCS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03938324
Anemia, Anemia, Hemolytic
Durham, North Carolina, United States
View Trial DetailsNCT03104543
Cardiovascular Diseases, Childhood Cancer
Seattle, Washington, United States
View Trial DetailsNCT06747910
Childhood Cancer, Hematologic Diseases
Memphis, Tennessee, United States
View Trial DetailsNCT03297034
Childhood Cancer, Neoplasms
Bern, Canton of Bern, Switzerland
View Trial Details