Text Size

Osteonecroses in Pediatric Patients With ALL (OPAL)

This study is currently recruiting participants.
Verified February 2013 by Heinrich-Heine University, Duesseldorf
Sponsor:
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
History of Changes

June 6, 2012
February 4, 2013
March 2012
March 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01619124 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Osteonecroses in Pediatric Patients With ALL
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

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum
Non-Probability Sample

Pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma, aged >= 10 and < 18 years
  • Osteonecrosis
  • Acute Lymphoblastic Leukaemia
  • Lymphoblastic Lymphoma
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
March 2018
March 2014   (final data collection date for primary outcome measure)

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
Both
10 Years to 18 Years
No
Contact: Michaela Kuhlen, Dr. med. +49 211 81 17687 Michaela.Kuhlen@med.uni-duesseldorf.de
Germany
 
NCT01619124
DKS 2011.11
No
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu, Heinrich-Heine University, Duesseldorf
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
Not Provided
Study Chair: Michaela Kuhlen, Dr. med. Heinrich-Heine University, Duesseldorf
Heinrich-Heine University, Duesseldorf
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP