Osteonecroses in Pediatric Patients With ALL (OPAL)
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| ClinicalTrials.gov Identifier: NCT01619124 |
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Recruitment Status : Unknown
Verified March 2014 by Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu, Heinrich-Heine University, Duesseldorf.
Recruitment status was: Recruiting
First Posted : June 14, 2012
Last Update Posted : March 5, 2014
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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 |
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| Osteonecrosis Acute Lymphoblastic Leukaemia Lymphoblastic Lymphoma |
| Study Type : | Observational |
| Estimated 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 : | March 2012 |
| Estimated Primary Completion Date : | March 2016 |
| Estimated Study Completion Date : | March 2020 |
- occurence of early ON stages [ Time Frame: 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
- ON incidence [ Time Frame: 6 years ]Prospective evaluation of incidence of asymptomatic and symptomatic ON in children and adolescents with ALL or LBL
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619124
| Contact: Michaela Kuhlen, Dr. med. | +49 211 81 17687 | Michaela.Kuhlen@med.uni-duesseldorf.de |
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| Study Chair: | Michaela Kuhlen, Dr. med. | Heinrich-Heine University, Duesseldorf |
| 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: | June 14, 2012 Key Record Dates |
| Last Update Posted: | March 5, 2014 |
| Last Verified: | March 2014 |
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osteonecrosis children pediatric acute lymphoblastic leukaemia lymphoblastic lymphoma |
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Lymphoma Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, Non-Hodgkin Osteonecrosis Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Diseases Musculoskeletal Diseases Necrosis Pathologic Processes |