Clinical trial NCT01619124: Osteonecroses in Pediatric Patients With ALL
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteonecrosis
Acute Lymphoblastic Leukaemia
Lymphoblastic Lymphoma
Keywords: osteonecrosis
children
pediatric
acute lymphoblastic leukaemia
lymphoblastic lymphoma
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2012-06-14
Enrollment: 400
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma, aged \>= 10 and \< 18 years

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.


Eligibility 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

Primary outcomes:
measure: occurence of early ON stages
timeFrame: 6 years
Secondary outcomes:
measure: ON incidence
timeFrame: 6 years
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Paediatric and Adolescend Medicine, University Aachen
city: Bonn
country: Germany
facility: Department of Pediatrics, Haematology and Oncology, University Bonn
city: Chemnitz
country: Germany
facility: Department for Children and Adolescent Helth Chemnitz gGmbH
city: Datteln
country: Germany
facility: Clinic of Pediatric and Adolescent Medicine, Vestische Caritas Clinic Datteln
city: Dresden
country: Germany
facility: Division of Pediatric Hematology and Oncology, University Children´s Hospital
city: Duesseldorf
country: Germany
facility: Clinic of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Heinrich Heine University
city: Erlangen
country: Germany
facility: Clinic of Pediatrics and Adolescent , Pediatric Hematology and Oncology
city: Essen
country: Germany
facility: Department of Pediatric-Oncology/-Hematology and clin. Immunology, University Medicine Essen
city: Frankfurt/Main
country: Germany
facility: Department of Pediatric Hematology, Oncology and Hemostaseology, Goethe-University, University Children's Hospital
city: Greifswald
country: Germany
facility: Pediatric Hematology and Oncology, University Medicine Greifswald
city: Hamburg
country: Germany
facility: Clinic of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Department of Pediatric and Adolescent Helth, University Medical Center Heidelberg
city: Herdecke
country: Germany
facility: Clinic and Polyclinic of Oncology and Haematology, Herdecke
city: Homburg
country: Germany
facility: Children's Hospital Medical Center, Pediatric Haematology and Oncology
city: Kassel
country: Germany
facility: Clinic of Pediatric Hematology and Oncology, Kassel
city: Kiel
country: Germany
facility: Department of Pediatrics, University Medicine of Schleswig-Holstein, Campus Kiel
city: Koblenz
country: Germany
facility: Clinic of Pediatric and Adolescent Helth, Koblenz-Mayen
city: Krefeld
country: Germany
facility: Helios Klinikum Krefeld Department of Paediatric and Adolescent Medicine
city: Minden
country: Germany
facility: Clinic of Oncology and Hematology, Johannes Wesling Klinikum
city: Neuendettelsau
country: Germany
facility: Department of Paediatric Oncology and Hematology, Cnopf'sche Kinderklinik
city: Oldenburg
country: Germany
facility: Department of General Pediatrics, Hematology and Oncology Oldenburg gGmbH
city: Rostock
country: Germany
facility: Clinic of Paediatric and Adolescend, University Rostock
city: Schwerin
country: Germany
facility: Clinic of Paediatric Oncology and Hematology, Helios Klinikum Schwerin
city: Trier
country: Germany
facility: Clinic Trier, Klinikum Mutterhaus der Bromäerinnen
city: Ulm
country: Germany
facility: Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Michaela Kuhlen, Dr. med.
role: STUDY_CHAIR
References: