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临床试验/NCT01393249
NCT01393249已完成不适用

PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With ALL

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Risk of pancreatitis

研究概览

简要总结

The purpose of this study is to create a model enabling us to predict pancreatitis, hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with Acute Lymphoblastic Leukemia.

详细描述

Leukemia is the leading cause of cancer in children in Europe and the U.S. with an annual incidence of appoximately 3,5 cases per 100.000 children 0-14,9 years.

Although the rate of cure has increased significantly, treatment is still unsuccesfull in appoximately 20 % of the patients. There is great variation in the how the individual patient processes the different chemotherapeutic agents. Furthermore there is a signifikant difference regarding the severity of sideeffects and toxicities. So far it has not been possible to predict which patients are at speciel risk of developing toxicities.

Acute pancreatitis is a severe sideffect/toxicity when treating ALL. Patients are at risk of developing pancreatitis, because of the drug Asparaginase. The condition can not be prevented and in severe cases, e.g. hemorhaggic pancreatitis the only solution is to discontinue the drug, in spite of the fact that Asparaginase is on of the most important drugs when treating leukemia.

In the current study we will map the occurence of pancreatitis, hepatotoxicity and hyperlipidemia among approximately 1000 children and adolescents with leukemia. This study is unique because it is the largest study of its kind regarding Asparaginase associated pancreatitis. Among other things it will involve extensive genetic analysis.

We believe that this study will improve the possibilities, not only, for individualized treatmentVi mener at dette studie vil forbedre mulighederne for individ orienteret behandling, but also for other studies like this regarding other toxicities in patients with cancer.

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
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • IR- or SR- type ALL, and treatment with Peg-Asparaginase

排除标准

  • HR ALL, and changing subgroup from IR or SR to HR

结局指标

主要结局

Risk of pancreatitis

时间窗: During asparaginase therapy

Risk of pancreatitis in relation to host genomic variants, inflammatory markers and ultrasound changes in the weeks prior to clinical pancreatitia

次要结局

  • Course of pancreatitis(In the months following pancreatitis)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kjeld Schmiegelow

Professor

Rigshospitalet, Denmark

研究点 (1)

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