KIdney aNd blooD prESsure ouTcomes in Childhood Cancer Survivors (CCS): Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Prevalence of Hypertension (HTN) from office blood pressure (vis blood pressure machine) at 3 years post cancer therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Pre-cancer severe CKD and/or previous kidney transplant
- •>19 years old at 3 years after cancer therapy completion
结局指标
主要结局
Prevalence of Hypertension (HTN) from office blood pressure (vis blood pressure machine) at 3 years post cancer therapy
时间窗: 3 years +/- 6 months after cancer therapy end
Defined by 2017 American Academy of Pediatrics (AAP) guidelines
Change in markers of kidney health (Albuminuria) (using lab values) between 3 and 5 years post cancer therapy
时间窗: Change from 3 to 5 years in Albuminuria
Change in albuminuria in mg/g
Prevalence of Chronic Kidney Disease (CKD) based on eGFR (using an equation) at 3 years post cancer therapy
时间窗: 3 years +/- 6 months after cancer therapy end
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
时间窗: 5 years +/- 6 months after cancer therapy end
CKD: Per Kidney Disease Improving Global Outcomes (KDIGO) guidelines
Change in markers of kidney health (Proteinuria) (using Lab values) between 3 and 5 years post cancer therapy
时间窗: Change from 3 to 5 years in Proteinuria
Change in proteinuria in mg/mmol
Prevalence of Hypertension (HTN) using Ambulatory Blood Pressure Measurement (ABPM) at 5 years post cancer therapy
时间窗: 5 years +/- 6 months after cancer therapy end
The presence of either ambulatory hypertension or masked hypertension
Change in markers of kidney health (eGFR)(using an equation) between 3 and 5 years post cancer therapy
时间窗: Change from 3 to 5 years in eGFR
Change in eGFR in milliliter (mL) /min/1.73m2
Change in markers of cardiovascular health (using blood tests) between 3 and 5 years post cancer therapy
时间窗: Change from 3 to 5 years
Change in BP percentile as per 2017 American Academy of Pediatrics (AAP) guidelines
次要结局
- Impact of Acute Kidney Injury (AKI) and Cardiometabolic risk factors (using blood work) at baseline on CKD outcomes(At baseline for independent factors on CKD outcomes at 3 and 5 years)
研究者
Michael Zappitelli
Staff Nephrologist and Senior Scientist
The Hospital for Sick Children