Design and Methods of the Pan-Canadian Applying Biomarkers to Minimize Long-Term Effects of Childhood/Adolescent Cancer Treatment (ABLE) Nephrotoxicity Study
Design and Methods of the Pan-Canadian Applying Biomarkers to Minimize Long-Term Effects of Childhood/Adolescent Cancer Treatment (ABLE) Nephrotoxicity Study
复制标题
泛加拿大应用生物标志物以尽量减少儿童/青少年癌症治疗 (ABLE) 肾毒性研究的长期影响的设计和方法
DOI：
--
复制
发表时间：
2017
影响因子：
1.7
通讯作者：
M. Zappitelli
中科院分区：
文献类型：
--
作者：
Kelly R. McMahon;S. Rod Rassekh;K. Schultz;M. Pinsk;T. Blydt;C. Mammen;R. Tsuyuki;P. Devarajan;G. Cuvelier;L. Mitchell;S. Baruchel;A. Palijan;B. Carleton;C. Ross;M. Zappitelli
背景：儿童癌症幸存者经历药物不良事件导致终身健康问题。应用生物标志物以减少儿童/青少年癌症治疗的长期影响（ABLE）团队的成立是为了验证和应用癌症治疗效果的生物标志物，目的是识别与血栓形成、移植物抗宿主病、听力损失和肾损害相关的癌症治疗并发症的高风险儿童。顺铂是一种引起急性和慢性肾毒性的化疗药物。顺铂治疗儿童急性肾损伤（AKI）和晚期肾结局的生物标志物数据有限。目的：描述泛加拿大ABLE肾毒性研究的设计和方法，该研究旨在评估尿生物标志物（中性粒细胞明胶质酶相关脂钙素[NGAL]和肾损伤分子-1 [KIM-1]）对AKI诊断的影响，并确定它们是否能预测长期肾脏结局（慢性肾脏疾病[CKD]、高血压）的风险。设计：这是一项为期3年的观察性前瞻性队列研究。环境：该研究包括12个加拿大儿科肿瘤中心。患者：目标招募目标为150名18岁以下接受顺铂治疗的患者。排除标准：估计肾小球滤过率(eGFR) <30 mL/min/1.73 m2或基线时已有肾移植的患者。测量方法：在顺铂输注期间（输注前、输注后立即、出院取样）测定血清肌酐（SCr）、尿NGAL和KIM-1。随访时，测量eGFR、微量白蛋白尿和血压，并收集结果。方法：结果：AKI是根据肾脏疾病：改善全球结果（KDIGO）指南的SCr标准定义的。CKD定义为eGFR < 90ml /min/1.73m2或白蛋白与肌酐比值≥3mg/mmol。高血压是按照指南定义的。程序：患者在第一个或第二个顺铂周期之前被招募。参与者在2次顺铂输注期间（AKI生物标志物验证）和顺铂治疗后3、12和36个月（晚期结果）进行评估。局限性：本研究样本量相对中等，随访时间较短。由于涉及多个站点，因此数据收集可能存在变异性。结论：ABLE将为研究晚期癌症治疗并发症的生物标志物提供一个全国性的平台。肾毒性研究是一项针对顺铂治疗儿童AKI生物标志物的新研究，将为晚期顺铂肾病结局和随访需求提供重要信息。
Background: Childhood cancer survivors experience adverse drug events leading to lifelong health issues. The Applying Biomarkers to Minimize Long-Term Effects of Childhood/Adolescent Cancer Treatment (ABLE) team was established to validate and apply biomarkers of cancer treatment effects, with a goal of identifying children at high risk of developing cancer treatment complications associated with thrombosis, graft-versus-host disease, hearing loss, and kidney damage. Cisplatin is a chemotherapy well known to cause acute and chronic nephrotoxicity. Data on biomarkers of acute kidney injury (AKI) and late renal outcomes in children treated with cisplatin are limited. Objective: To describe the design and methods of the pan-Canadian ABLE Nephrotoxicity study, which aims to evaluate urine biomarkers (neutrophil gelatinase–associated lipocalin [NGAL] and kidney injury molecule-1 [KIM-1]) for AKI diagnosis, and determine whether they predict risk of long-term renal outcomes (chronic kidney disease [CKD], hypertension). Design: This is a 3-year observational prospective cohort study. Setting: The study includes 12 Canadian pediatric oncology centers. Patients: The target recruitment goal is 150 patients aged less than 18 years receiving cisplatin. Exclusion criteria: Patients with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 or a pre-existing renal transplantation at baseline. Measurements: Serum creatinine (SCr), urine NGAL, and KIM-1 are measured during cisplatin infusion episodes (pre-infusion, immediate post-infusion, discharge sampling). At follow-up visits, eGFR, microalbuminuria, and blood pressure are measured and outcomes are collected. Methods: Outcomes: AKI is defined as per SCr criteria of the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. CKD is defined as eGFR <90 mL/min/1.73m2 or albumin-to-creatinine ratio≥3mg/mmol. Hypertension is defined as per guidelines. Procedure: Patients are recruited before their first or second cisplatin cycle. Participants are evaluated during 2 cisplatin infusion episodes (AKI biomarker validation) and at 3, 12, and 36 months post-cisplatin treatment (late outcomes). Limitations: The study has a relatively moderate sample size and short follow-up duration. There is potential for variability in data collection since multiple sites are involved. Conclusions: ABLE will provide a national platform to study biomarkers of late cancer treatment complications. The Nephrotoxicity study is a novel study of AKI biomarkers in children treated with cisplatin that will greatly inform on late cisplatin renal outcomes and follow-up needs.
登录
查看更多内容
影响因子：
13.6
作者：
Parikh, Chirag R.;Devarajan, Prasad;Krawczeski, Catherine D.
通讯作者：
Krawczeski, Catherine D.
影响因子：
19.6
作者：
Deng, JP;Kohda, Y;Star, RA
通讯作者：
Star, RA
DOI：
10.2215/cjn.10971012
发表时间：
2013-07-01
影响因子：
9.8
作者：
Parikh, Chirag R.;Thiessen-Philbrook, Heather;Coca, Steven G.
通讯作者：
Coca, Steven G.
DOI：
10.1097/01.asn.0000088027.54400.c6
发表时间：
2003-10-01
影响因子：
13.6
作者：
Mishra, J;Ma, Q;Devarajan, P
通讯作者：
Devarajan, P
影响因子：
19.6
作者：
Han, WK;Bailly, V;Bonventre, JV
通讯作者：
Bonventre, JV