Clinical Trial: The British Osteonecrosis Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: The British Osteonecrosis Study: A Prospective Multi-centre Study to Examine the Natural History of Osteonecrosis in Older Children, Teenagers

Brief Summary: 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.

Detailed Summary:

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 markers of bone turnover.

Investigations

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

  1. At diagnosis - highest white cell count, immunophenotype, cytogenetics, molecular results; albumin; lipid profile; vitamin D level
  2. At the end of induction - MRD result, flow cytometry from end of induction bone marrow; albumin; lipid profile

DEXA scans should be performed on all children >10y old and on treatment for ALL. It is recommended that a DEXA scan is performed at diagnosis and then annually. The results of these DEXA sca
Sponsor: University of Leeds

Current Primary Outcome: Incidence of osteonecrosis [ Time Frame: 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.


Original Primary Outcome: Incidence of osteonecrosis [ Time Frame: 3 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.


Current Secondary Outcome:

  • Risk factors for development of osteonecrosis. [ Time Frame: 5 years ]
    The risk factors for progression and the development of symptomatic osteonecrosis in this population.
  • Radiological features for prediction of progression of osteonecrosis [ Time Frame: 5 years ]
    specific radiological features that predict for either progression or regression in those with asymptomatic osteonecrosis


Original Secondary Outcome:

  • Risk factors for development of osteonecrosis. [ Time Frame: 3 years ]
    The risk factors for progression and the development of symptomatic osteonecrosis in this population.
  • Radiological features for prediction of progression of osteonecrosis [ Time Frame: 3 years ]
    specific radiological features that predict for either progression or regression in those with asymptomatic osteonecrosis


Information By: University of Leeds

Dates:
Date Received: November 4, 2015
Date Started: October 2016
Date Completion: October 2023
Last Updated: May 18, 2016
Last Verified: May 2016