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OPAL: Osteonecroses in Pediatric Patients With ALL

Sponsor
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu (Other)
Overall Status
Unknown status
CT.gov ID
NCT01619124
Collaborator
(none)
400
Enrollment
25
Locations
96
Duration (Months)
16
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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
    Study Start Date :
    Mar 1, 2012
    Anticipated Primary Completion Date :
    Mar 1, 2016
    Anticipated Study Completion Date :
    Mar 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. ON incidence [6 years]

      Prospective evaluation of incidence of asymptomatic and symptomatic ON in children and adolescents with ALL or LBL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Paediatric and Adolescend Medicine, University Aachen Aachen Germany 52074
    2 Department of Pediatrics, Haematology and Oncology, University Bonn Bonn Germany 53113
    3 Department for Children and Adolescent Helth Chemnitz gGmbH Chemnitz Germany 09009
    4 Clinic of Pediatric and Adolescent Medicine, Vestische Caritas Clinic Datteln Datteln Germany 45711
    5 Division of Pediatric Hematology and Oncology, University Children´s Hospital Dresden Germany 01307
    6 Clinic of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Heinrich Heine University Duesseldorf Germany 40225
    7 Clinic of Pediatrics and Adolescent , Pediatric Hematology and Oncology Erlangen Germany 91054
    8 Department of Pediatric-Oncology/-Hematology and clin. Immunology, University Medicine Essen Essen Germany 45122
    9 Department of Pediatric Hematology, Oncology and Hemostaseology, Goethe-University, University Children's Hospital Frankfurt/Main Germany 60590
    10 Pediatric Hematology and Oncology, University Medicine Greifswald Greifswald Germany 17475
    11 Clinic of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf Hamburg Germany 20246
    12 Department of Pediatric and Adolescent Helth, University Medical Center Heidelberg Heidelberg Germany 69120
    13 Clinic and Polyclinic of Oncology and Haematology, Herdecke Herdecke Germany 58313
    14 Children's Hospital Medical Center, Pediatric Haematology and Oncology Homburg Germany 66421
    15 Clinic of Pediatric Hematology and Oncology, Kassel Kassel Germany 34125
    16 Department of Pediatrics, University Medicine of Schleswig-Holstein, Campus Kiel Kiel Germany 24105
    17 Clinic of Pediatric and Adolescent Helth, Koblenz-Mayen Koblenz Germany 56073
    18 Helios Klinikum Krefeld Department of Paediatric and Adolescent Medicine Krefeld Germany 47805
    19 Clinic of Oncology and Hematology, Johannes Wesling Klinikum Minden Germany 32429
    20 Department of Paediatric Oncology and Hematology, Cnopf'sche Kinderklinik Neuendettelsau Germany 91564
    21 Department of General Pediatrics, Hematology and Oncology Oldenburg gGmbH Oldenburg Germany 26133
    22 Clinic of Paediatric and Adolescend, University Rostock Rostock Germany 18057
    23 Clinic of Paediatric Oncology and Hematology, Helios Klinikum Schwerin Schwerin Germany 19049
    24 Clinic Trier, Klinikum Mutterhaus der Bromäerinnen Trier Germany 54290
    25 Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm Ulm Germany 89075

    Sponsors and Collaborators

    • Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu

    Investigators

    • Study Chair: Michaela Kuhlen, Dr. med., Heinrich-Heine University, Duesseldorf

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu, principal investigator and senior physician university paediatric clinic, Heinrich-Heine University, Duesseldorf
    ClinicalTrials.gov Identifier:
    NCT01619124
    Other Study ID Numbers:
    • DKS 2011.11
    First Posted:
    Jun 14, 2012
    Last Update Posted:
    Mar 5, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu, principal investigator and senior physician university paediatric clinic, Heinrich-Heine University, Duesseldorf
    osteonecrosis
    children
    pediatric
    acute lymphoblastic leukaemia
    lymphoblastic lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Lymphoma, Non-Hodgkin
    Osteonecrosis

    Study Results

    No Results Posted as of Mar 5, 2014