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临床试验/NCT02598401
NCT02598401Unknown不适用

The British Osteonecrosis Study: A Prospective Multi-centre Study to Examine the Natural History of Osteonecrosis in Older Children, Teenagers and Young Adults With Acute Lymphoblastic Leukaemia and Lymphoblastic Lymphoma

University of Leeds4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年8月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
4
主要终点
Incidence of osteonecrosis

研究概览

简要总结

The aim of this research is to examine the natural history of osteonecrosis in older children, teenagers and young adults with acute lymphoblastic leukaemia and lymphoblastic lymphoma within the UK. In addition to using and validating new, internationally agreed, standard definitions for osteonecrosis, this study will provide the data needed to develop a radiological classification which correlates with clinical status.

详细描述

Children, teenagers or young adults between the age of 10 (including the day of the 10th birthday) and 24 years 364 days (at the time of diagnosis) with a first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL) diagnosed under standard criteria are eligible for BONES.

The recruitment target is 50 over a 2 year period, which is based on an anticipated ascertainment target of 75%.

Information will be collected on basic demographics, presenting features and diagnosis at initial recruitment. Further data will be collected at the end of induction to ascertain treatment and response, along with results of relevant investigations performed in induction detailed below. Clinical information collected will include height, weight and puberty stage. At the four subsequent time points when MRI imagine is performed further data will also be collected, including a physiotherapy assessment using a structured assessment tool and child health assessment questionnaire, and biochemical information.

Investigations

The results of the following investigations, usually performed as part of the routine assessment, will be collected:

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 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL)

排除标准

  • inability to have MRI scans of lower limbs

结局指标

主要结局

Incidence of osteonecrosis

时间窗: 5 years

The incidence of osteonecrosis in older children, teenagers and young adults being treated for acute lymphoblastic leukaemia (ALL) in the UK at different time points in their treatment.

次要结局

  • Risk factors for development of osteonecrosis.(5 years)
  • Radiological features for prediction of progression of osteonecrosis(5 years)

研究者

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

Nadia laila Amin

Chief Investigator

University of Leeds

研究点 (4)

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