Clinical trial · Observational
Osteonecroses in Pediatric Patients With ALL
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukaemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoblastic Lymphoma | Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Osteonecrosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- occurence of early ON stages
- timeFrame
- 6 years
- description
- 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
Secondary outcomes (1)
- measure
- ON incidence
- timeFrame
- 6 years
- description
- Prospective evaluation of incidence of asymptomatic and symptomatic ON in children and adolescents with ALL or LBL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available