Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
400 participants
OBSERVATIONAL
2012-03-31
2020-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma
NCT04401267
Imaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD
NCT06093334
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia
NCT01117441
Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma (ALCL 99)
NCT00006455
Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)
NCT02303522
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
10 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
principal investigator and senior physician university paediatric clinic
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michaela Kuhlen, Dr. med.
Role: STUDY_CHAIR
Heinrich-Heine University, Duesseldorf
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Clinic of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Department of Pediatric and Adolescent Helth, University Medical Center Heidelberg
Heidelberg, , Germany
Clinic and Polyclinic of Oncology and Haematology, Herdecke
Herdecke, , Germany
Children's Hospital Medical Center, Pediatric Haematology and Oncology
Homburg, , Germany
Clinic of Pediatric Hematology and Oncology, Kassel
Kassel, , Germany
Department of Pediatrics, University Medicine of Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Clinic of Pediatric and Adolescent Helth, Koblenz-Mayen
Koblenz, , Germany
Helios Klinikum Krefeld Department of Paediatric and Adolescent Medicine
Krefeld, , Germany
Clinic of Oncology and Hematology, Johannes Wesling Klinikum
Minden, , Germany
Department of Paediatric Oncology and Hematology, Cnopf'sche Kinderklinik
Neuendettelsau, , Germany
Department of General Pediatrics, Hematology and Oncology Oldenburg gGmbH
Oldenburg, , Germany
Clinic of Paediatric and Adolescend, University Rostock
Rostock, , Germany
Clinic of Paediatric Oncology and Hematology, Helios Klinikum Schwerin
Schwerin, , Germany
Clinic Trier, Klinikum Mutterhaus der Bromäerinnen
Trier, , Germany
Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm
Ulm, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Rolf Mertens, Prof. Dr.
Role: primary
Dagmar Dilloo, Prof. Dr.
Role: primary
Thomas Scholbach, Prof. Dr.
Role: primary
Thomas Wiesel, Dr.
Role: primary
Meinolf Suttorp, Prof. Dr.
Role: primary
M. Metzler, Dr.
Role: primary
M. Schündeln, Dr.
Role: primary
Thomas Klingebiel, Prof. Dr.
Role: primary
Holger Lode, Prof. Dr.
Role: primary
Reinhard Schneppenheim, Prof. Dr.
Role: primary
Wolfgang Behnisch, Dr.
Role: primary
Alfred Längler, Dr. med.
Role: primary
Norbert Graf, Prof. Dr.
Role: primary
Michaela Nathrath, Prof.
Role: primary
Gunnar Cario, Dr.
Role: primary
Rudolf Ferrari, Dr.
Role: primary
Thomas Imschweiler, Dr.
Role: primary
Tim Niehues, Prof.Dr.
Role: backup
Bernhard Erdlenbruch, Prof. Dr.
Role: primary
Wolfram Scheurlen, Prof. Dr.
Role: primary
Hermann Müller, Prof. Dr.
Role: primary
Carl-Friedrich Classen, Dr.
Role: primary
Christian Güttel, Dr.
Role: primary
Stefan Weis, Dr.
Role: primary
Klaus-Michael Debatin, Prof. Dr.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DKS 2011.11
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.