Osteonecroses in Pediatric Patients With ALL
OPAL
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
1 other identifier
observational
400
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 6, 2012
CompletedFirst Posted
Study publicly available on registry
June 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedMarch 5, 2014
March 1, 2014
4 years
June 6, 2012
March 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
occurence of early ON stages
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
6 years
Secondary Outcomes (1)
ON incidence
6 years
Eligibility Criteria
Pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma, aged \>= 10 and \< 18 years
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Department of Paediatric and Adolescend Medicine, University Aachen
Aachen, 52074, Germany
Department of Pediatrics, Haematology and Oncology, University Bonn
Bonn, 53113, Germany
Department for Children and Adolescent Helth Chemnitz gGmbH
Chemnitz, 09009, Germany
Clinic of Pediatric and Adolescent Medicine, Vestische Caritas Clinic Datteln
Datteln, 45711, Germany
Division of Pediatric Hematology and Oncology, University Children´s Hospital
Dresden, 01307, Germany
Clinic of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Heinrich Heine University
Düsseldorf, 40225, Germany
Clinic of Pediatrics and Adolescent , Pediatric Hematology and Oncology
Erlangen, 91054, Germany
Department of Pediatric-Oncology/-Hematology and clin. Immunology, University Medicine Essen
Essen, 45122, Germany
Department of Pediatric Hematology, Oncology and Hemostaseology, Goethe-University, University Children's Hospital
Frankfurt am Main, 60590, Germany
Pediatric Hematology and Oncology, University Medicine Greifswald
Greifswald, 17475, Germany
Clinic of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Department of Pediatric and Adolescent Helth, University Medical Center Heidelberg
Heidelberg, 69120, Germany
Clinic and Polyclinic of Oncology and Haematology, Herdecke
Herdecke, 58313, Germany
Children's Hospital Medical Center, Pediatric Haematology and Oncology
Homburg, 66421, Germany
Clinic of Pediatric Hematology and Oncology, Kassel
Kassel, 34125, Germany
Department of Pediatrics, University Medicine of Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Clinic of Pediatric and Adolescent Helth, Koblenz-Mayen
Koblenz, 56073, Germany
Helios Klinikum Krefeld Department of Paediatric and Adolescent Medicine
Krefeld, 47805, Germany
Clinic of Oncology and Hematology, Johannes Wesling Klinikum
Minden, 32429, Germany
Department of Paediatric Oncology and Hematology, Cnopf'sche Kinderklinik
Neuendettelsau, 91564, Germany
Department of General Pediatrics, Hematology and Oncology Oldenburg gGmbH
Oldenburg, 26133, Germany
Clinic of Paediatric and Adolescend, University Rostock
Rostock, 18057, Germany
Clinic of Paediatric Oncology and Hematology, Helios Klinikum Schwerin
Schwerin, 19049, Germany
Clinic Trier, Klinikum Mutterhaus der Bromäerinnen
Trier, 54290, Germany
Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm
Ulm, 89075, Germany
Biospecimen
whole blood, serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michaela Kuhlen, Dr. med.
Heinrich-Heine University, Duesseldorf
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator and senior physician university paediatric clinic
Study Record Dates
First Submitted
June 6, 2012
First Posted
June 14, 2012
Study Start
March 1, 2012
Primary Completion
March 1, 2016
Study Completion
March 1, 2020
Last Updated
March 5, 2014
Record last verified: 2014-03