Osteonecroses in paediatric Patients with A

Recruiting

• Conditions: M87.1; C91.0; C83.5; Osteonecrosis due to drugs; Acute lymphoblastic leukaemia [ALL]; Lymphoblastic (diffuse) lymphoma

• Registration Number: DRKS00004421
• Lead Sponsor: Heinrich-Heine-Universität DüsseldorfIm Auftrag desUniversitätsklinikums Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

diagnosis of ALL or LBL
- age at ALL/LBLdiagnosis =10 and <18 years
- patient in trial ALL-BFM or CoALL in Germany
- treatment in OPAL associated hospital
- signed informed consent

Exclusion Criteria

Relapse of ALL or LB

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the rate detectable by MRI (still) asymptomatic patients with early<br>Osteonecrosis stages (I + II) among patients, the symptomatic later in<br>Osteonecrosis develop (during the 2 years of treatment)

Secondary Outcome Measures

Name	Time	Method
Determine the time of the ALL-/LBL-Diagnose to earlier detection osteonecrosis<br>Stages (I + II) by MRI determining the time between the first radiographic evidence of osteonekroseverdächtigen MRI changes and the onset of clinical symptoms<br>Prospective investigation of the incidence of asymptomatic and symptomatic<br>Osteonecrosis in children and adolescents with ALL or LBL<br>Prospective systematic recording of the clinical course of patients with asymptomatic and symptomatic osteonecrosis<br>(2 years)