Osteonecroses in Pediatric Patients With ALL (OPAL)
This study is currently recruiting participants.
Verified February 2013 by Heinrich-Heine University, Duesseldorf
Sponsor:
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
Information provided by (Responsible Party):
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01619124
First received: June 6, 2012
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
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 |
|---|
|
Osteonecrosis Acute Lymphoblastic Leukaemia Lymphoblastic Lymphoma |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Heinrich-Heine University, Duesseldorf:
Primary Outcome Measures:
- occurence of early ON stages [ Time Frame: 6 years ] [ Designated as safety issue: No ]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:
- ON incidence [ Time Frame: 6 years ] [ Designated as safety issue: No ]Prospective evaluation of incidence of asymptomatic and symptomatic ON in children and adolescents with ALL or LBL
Biospecimen Retention: Samples With DNA
whole blood, serum
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 10 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma, aged >= 10 and < 18 years
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619124
Contacts
| Contact: Michaela Kuhlen, Dr. med. | +49 211 81 17687 | Michaela.Kuhlen@med.uni-duesseldorf.de |
Locations
| Germany | |
| Department of Paediatric and Adolescend Medicine, University Aachen | Recruiting |
| Aachen, Germany, 52074 | |
| Contact: Rolf Mertens, Prof. Dr. +49-(0)241-8089902 | |
| Principal Investigator: Rolf Mertens, Prof. Dr. | |
| Department of Pediatrics, Haematology and Oncology, University Bonn | Recruiting |
| Bonn, Germany, 53113 | |
| Contact: Dagmar Dilloo, Prof. Dr. +49-(0)2873-3254 | |
| Principal Investigator: Carola Weber, Dr. med. | |
| Department for Children and Adolescent Helth Chemnitz gGmbH | Recruiting |
| Chemnitz, Germany, 09009 | |
| Contact: Thomas Scholbach, Prof. Dr. +49-(0)371-33324124 | |
| Principal Investigator: André Hofmann, Dr. med. | |
| Division of Pediatric Hematology and Oncology, University Children´s Hospital | Recruiting |
| Dresden, Germany, 01307 | |
| Contact: Meinolf Suttorp, Prof. Dr. +49-(0)351-4583522 | |
| Principal Investigator: Meinolf Suttorp, Prof. Dr. | |
| Clinic of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Heinrich Heine University | Recruiting |
| Duesseldorf, Germany, 40225 | |
| Contact: Michaela Kuhlen, Dr. med. +49(0)211-811-7687 Michaela.Kuhlen@med.uni-duesseldorf.de | |
| Department of Pediatric Hematology, Oncology and Hemostaseology, Goethe-University, University Children's Hospital | Recruiting |
| Frankfurt/Main, Germany, 60590 | |
| Contact: Thomas Klingebiel, Prof. Dr. +49-(0)69-6301-5094 | |
| Principal Investigator: Thomas Klingebiel, Prof. Dr. | |
| Pediatric Hematology and Oncology, University Medicine Greifswald | Recruiting |
| Greifswald, Germany, 17475 | |
| Contact: Holger Lode, Prof. Dr. +49-(0)3834-8622390 | |
| Principal Investigator: Hagen Graf Einsiedel, Dr. | |
| Clinic of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf | Recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Reinhard Schneppenheim, Prof. Dr. +49-(0)74105-3796 | |
| Principal Investigator: Gabriele Escherich, Dr. | |
| Clinic and Polyclinic of Oncology and Haematology, Herdecke | Recruiting |
| Herdecke, Germany, 58313 | |
| Contact: Alfred Längler, Dr. med. +49-(0)2330-623893 | |
| Principal Investigator: Alfred Längler, Dr. med. | |
| Children's Hospital Medical Center, Pediatric Haematology and Oncology | Recruiting |
| Homburg, Germany, 66421 | |
| Contact: Norbert Graf, Prof. Dr. +49-(0)6841-1628411 | |
| Principal Investigator: Norbert Graf, Prof. Dr. | |
| Helios Klinikum Krefeld Department of Paediatric and Adolescent Medicine | Not yet recruiting |
| Krefeld, Germany, 47805 | |
| Contact: Thomas Imschweiler, Dr. +49-(0)2151-322301 | |
| Contact: Tim Niehues, Prof.Dr. +49-(0)2151-322301 | |
| Principal Investigator: Thomas Imschweiler, Dr. | |
| Clinic of Oncology and Hematology, Johannes Wesling Klinikum | Recruiting |
| Minden, Germany, 32429 | |
| Contact: Bernhard Erdlenbruch, Prof. Dr. +49-(0)571-790-54001 | |
| Principal Investigator: Bernhard Erdlenbruch, Prof. Dr. | |
| Department of Paediatric Oncology and Hematology, Cnopf`sche Kinderklinik | Recruiting |
| Neuendettelsau, Germany, 91564 | |
| Contact: Wolfram Scheurlen, Prof. Dr. +49-(0)911-33403000 | |
| Principal Investigator: Wolfram Scheurlen, Prof.Dr. | |
| Department of General Pediatrics, Hematology and Oncology Oldenburg gGmbH | Recruiting |
| Oldenburg, Germany, 26133 | |
| Contact: Hermann Müller, Prof. Dr. +49-(0)441-403-2013 | |
| Principal Investigator: H. Müller, Prof. Dr. | |
| Clinic of Paediatric and Adolescend, University Rostock | Recruiting |
| Rostock, Germany, 18057 | |
| Contact: Carl-Friedrich Classen, Dr. +49-(0)381-4947262 | |
| Principal Investigator: Carl-Friedrich Classen, Dr. | |
| Clinic of Paediatric Oncology and Hematology, Helios Klinikum Schwerin | Recruiting |
| Schwerin, Germany, 19049 | |
| Contact: Christian Güttel, Dr. +49-(0)385-520-2710 | |
| Principal Investigator: Christian Güttel, Dr. | |
| Clinic Trier, Klinikum Mutterhaus der Bromäerinnen | Recruiting |
| Trier, Germany, 54290 | |
| Contact: Stefan Weis, Dr. +49-(0)651-94782593 | |
| Principal Investigator: Stefan Weis, Dr. | |
| Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm | Recruiting |
| Ulm, Germany, 89075 | |
| Contact: Klaus-Michael Debatin, Prof. Dr. +49-(0)731-50057482 | |
| Principal Investigator: Daniel Steinbach, Prof. Dr. | |
Sponsors and Collaborators
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
Investigators
| Study Chair: | Michaela Kuhlen, Dr. med. | Heinrich-Heine University, Duesseldorf |
More Information
Additional Information:
No publications 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 History of Changes |
| Other Study ID Numbers: | DKS 2011.11 |
| Study First Received: | June 6, 2012 |
| Last Updated: | February 4, 2013 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Heinrich-Heine University, Duesseldorf:
|
osteonecrosis children pediatric acute lymphoblastic leukaemia lymphoblastic lymphoma |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma Osteonecrosis Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Diseases Musculoskeletal Diseases Necrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013