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Clinical Trials/NCT01619124
NCT01619124
Unknown
Not Applicable

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

Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu25 sites in 1 country400 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteonecrosis
Sponsor
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
Enrollment
400
Locations
25
Primary Endpoint
occurence of early ON stages
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
March 2020
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
Responsible Party
Sponsor Investigator
Principal Investigator

Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu

principal investigator and senior physician university paediatric clinic

Heinrich-Heine University, Duesseldorf

Eligibility Criteria

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

Outcomes

Primary Outcomes

occurence of early ON stages

Time Frame: 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 Outcomes

  • ON incidence(6 years)

Study Sites (25)

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