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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01619124

Acronym

OPAL

Enrollment

400

Registered

2012-06-14

Start date

2012-03-31

Completion date

2020-03-31

Last updated

2014-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukaemia, Lymphoblastic Lymphoma, Osteonecrosis

Keywords

osteonecrosis, children, pediatric, acute lymphoblastic leukaemia, lymphoblastic lymphoma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
occurence of early ON stages	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

Secondary

Measure	Time frame	Description
ON incidence	6 years	Prospective evaluation of incidence of asymptomatic and symptomatic ON in children and adolescents with ALL or LBL

Countries

Germany

Contacts

Primary ContactMichaela Kuhlen, Dr. med.

Michaela.Kuhlen@med.uni-duesseldorf.de+49 211 81 17687

Outcome results