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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
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.
Age
10 - 18 years
Sex
ALL
Healthy Volunteers
No
Department of Paediatric and Adolescend Medicine, University Aachen
Aachen, Germany
Department of Pediatrics, Haematology and Oncology, University Bonn
Bonn, Germany
Department for Children and Adolescent Helth Chemnitz gGmbH
Chemnitz, Germany
Clinic of Pediatric and Adolescent Medicine, Vestische Caritas Clinic Datteln
Datteln, Germany
Division of Pediatric Hematology and Oncology, University Children´s Hospital
Dresden, Germany
Clinic of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Heinrich Heine University
Düsseldorf, Germany
Clinic of Pediatrics and Adolescent , Pediatric Hematology and Oncology
Erlangen, Germany
Department of Pediatric-Oncology/-Hematology and clin. Immunology, University Medicine Essen
Essen, Germany
Department of Pediatric Hematology, Oncology and Hemostaseology, Goethe-University, University Children's Hospital
Frankfurt am Main, Germany
Pediatric Hematology and Oncology, University Medicine Greifswald
Greifswald, Germany
Start Date
March 1, 2012
Primary Completion Date
March 1, 2016
Completion Date
March 1, 2020
Last Updated
March 5, 2014
400
ESTIMATED participants
Lead Sponsor
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
NCT05292664
NCT04195633
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