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临床试验/NCT01619124
NCT01619124Unknown不适用

Part I: Incidence, Clinical Course and Significance of MRI for Early Diagnosis of Osteonecrosis in Children and Adolescents With Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) Part II: Susceptibility for Aseptic Osteonecroses in Children and Adolescents With Chemotherapy for ALL or LBL

Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu25 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
25
主要终点
occurence of early ON stages

研究概览

简要总结

Nowadays approximately 80% of children and adolescents with acute lymphoblastic leukaemia (ALL) or lymphoblastic lymphoma (LBL) can be cured and become long-term survivors. Avascular osteonecroses (ON) appear as serious side-effect of antileukaemic treatment. Frequently ON are first diagnosed at higher and than irreversible stages (ARCO III, IV). At these advanced stages curative treatment options are not available. Hence ON are associated with considerable morbidity concerning pain and immobility and go along with long-term impairment of quality of life. Therefore early diagnosis of ON in the follow-up of children and young adults with ALL or LBL is a pressing object.

Within the prospective multicentric observational OPAL-trial patients at risk (aged 10 years or older) treated according to the clinical trials ALL-BFM(Berlin-Frankfurt-Muenster Study Group), COALL or NHL (Non Hodgkin Lymphoma)-BFM in Germany should be examined with regard to the development of ON. By using a treatment associated, risk orientated assessment and examination incidence, symptoms and the clinical course of ON are investigated. The validity of MRI screening in the early diagnosis of ON in children and young adults is analysed.

Systematical investigation of patients under antileukaemic treatment is intended to contribute to risk adapted diagnostic strategies and to serve as data base for the subsequent evaluation of preventive and interventional approaches for the treatment of ON. Long-term objective is the reduction of ON-associated morbidity.

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

入选标准

  • diagnosis of ALL or LBL
  • age at diagnosis of ALL or LBL ≥ 10 and < 18 years
  • study patient of AIEOP( Associazione Italiana Ematologia ed Oncologia Pediatrica)-BFM, COALL or NHL-BFM in Germany
  • treatment in a hospital participating in OPAL
  • written informed consent

排除标准

  • relapse of ALL or LBL
  • every non evidence based treatment (pharmacological, orthopaedic-conservative, orthopaedic operative) aiming at the prevention of ON during study participation
  • pacemaker, other MRI prohibited devices
  • metal implants in the field of view, other MRI prohibited implants
  • pregnancy
  • claustrophobia

结局指标

主要结局

occurence of early ON stages

时间窗: 6 years

Calculation of the rate of by MRI detectable (still) asymptomatic patients with early ON stages (I and II) within the patients who develop symptomatic ON in the further course

次要结局

  • ON incidence(6 years)

研究者

发起方
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu

principal investigator and senior physician university paediatric clinic

Heinrich-Heine University, Duesseldorf

研究点 (25)

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