OsteonecrosisOPALNCT01619124
Osteonecroses in Pediatric Patients With ALL
An observational study of Osteonecrosis and Acute Lymphoblastic Leukaemia, run by Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu at 25 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Osteonecrosis, Acute Lymphoblastic Leukaemia, Lymphoblastic Lymphoma
- How many people
- 400 participants
- Where
- 25 sitesGermany
- Study dates
- Mar 2012to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma, aged >= 10 and < 18 years
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Germany25 sites, 25 recruiting
- Recruiting
Department of Paediatric and Adolescend Medicine, University Aachen
Aachen, 52074
Rolf Mertens, Prof. Dr., +49-(0)241-8089902
Rolf Mertens, Prof. Dr.
- Recruiting
Department of Pediatrics, Haematology and Oncology, University Bonn
Bonn, 53113
Dagmar Dilloo, Prof. Dr., +49-(0)2873-3254
Carola Weber, Dr. med.
- Recruiting
Department for Children and Adolescent Helth Chemnitz gGmbH
Chemnitz, 09009
Thomas Scholbach, Prof. Dr., +49-(0)371-33324124
André Hofmann, Dr. med.
- Recruiting
Clinic of Pediatric and Adolescent Medicine, Vestische Caritas Clinic Datteln
Datteln, 45711
Thomas Wiesel, Dr., +49(0)2363-975-392
Thomas Wiesel, Dr.
- Recruiting
Division of Pediatric Hematology and Oncology, University Children´s Hospital
Dresden, 01307
Meinolf Suttorp, Prof. Dr., +49-(0)351-4583522
Meinolf Suttorp, Prof. Dr.
- Recruiting
Clinic of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Heinrich Heine University
Düsseldorf, 40225
Michaela Kuhlen, Dr. med., +49(0)211-811-7687, Michaela.Kuhlen@med.uni-duesseldorf.de
- Recruiting
Clinic of Pediatrics and Adolescent , Pediatric Hematology and Oncology
Erlangen, 91054
M. Metzler, Dr., +49-(0)9131-8533117
M. Metzler, Dr.
- Recruiting
Department of Pediatric-Oncology/-Hematology and clin. Immunology, University Medicine Essen
Essen, 45122
M. Schündeln, Dr., +49-(0)201-723-84282
M. Schündeln, Dr.
- Recruiting
Department of Pediatric Hematology, Oncology and Hemostaseology, Goethe-University, University Children's Hospital
Frankfurt am Main, 60590
Thomas Klingebiel, Prof. Dr., +49-(0)69-6301-5094
Thomas Klingebiel, Prof. Dr.
- Recruiting
Pediatric Hematology and Oncology, University Medicine Greifswald
Greifswald, 17475
Holger Lode, Prof. Dr., +49-(0)3834-8622390
Hagen Graf Einsiedel, Dr.
- Recruiting
Clinic of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Reinhard Schneppenheim, Prof. Dr., +49-(0)74105-3796
Gabriele Escherich, Dr.
- Recruiting
Department of Pediatric and Adolescent Helth, University Medical Center Heidelberg
Heidelberg, 69120
Wolfgang Behnisch, Dr., +49 (0)6221-564555
Wolfgang Behnisch, Dr.
- Recruiting
Clinic and Polyclinic of Oncology and Haematology, Herdecke
Herdecke, 58313
Alfred Längler, Dr. med., +49-(0)2330-623893
Alfred Längler, Dr. med.
- Recruiting
Children's Hospital Medical Center, Pediatric Haematology and Oncology
Homburg, 66421
Norbert Graf, Prof. Dr., +49-(0)6841-1628411
Norbert Graf, Prof. Dr.
- Recruiting
Clinic of Pediatric Hematology and Oncology, Kassel
Kassel, 34125
Michaela Nathrath, Prof., +49 (0)561-980-3504
Michaela Nathrath, Prof.
- Recruiting
Department of Pediatrics, University Medicine of Schleswig-Holstein, Campus Kiel
Kiel, 24105
Gunnar Cario, Dr., +49-(0)431-597-1834
Gunnar Cario, Dr.
- Recruiting
Clinic of Pediatric and Adolescent Helth, Koblenz-Mayen
Koblenz, 56073
Rudolf Ferrari, Dr., +49 (0)261-499- 2602
Rudolf Ferrari, Dr.
- Recruiting
Helios Klinikum Krefeld Department of Paediatric and Adolescent Medicine
Krefeld, 47805
Thomas Imschweiler, Dr., +49-(0)2151-322301
Tim Niehues, Prof.Dr., +49-(0)2151-322301
- Recruiting
Clinic of Oncology and Hematology, Johannes Wesling Klinikum
Minden, 32429
Bernhard Erdlenbruch, Prof. Dr., +49-(0)571-790-54001
Bernhard Erdlenbruch, Prof. Dr.
- Recruiting
Department of Paediatric Oncology and Hematology, Cnopf'sche Kinderklinik
Neuendettelsau, 91564
Wolfram Scheurlen, Prof. Dr., +49-(0)911-33403000
Wolfram Scheurlen, Prof.Dr.
- Recruiting
Department of General Pediatrics, Hematology and Oncology Oldenburg gGmbH
Oldenburg, 26133
Hermann Müller, Prof. Dr., +49-(0)441-403-2013
H. Müller, Prof. Dr.
- Recruiting
Clinic of Paediatric and Adolescend, University Rostock
Rostock, 18057
Carl-Friedrich Classen, Dr., +49-(0)381-4947262
Carl-Friedrich Classen, Dr.
- Recruiting
Clinic of Paediatric Oncology and Hematology, Helios Klinikum Schwerin
Schwerin, 19049
Christian Güttel, Dr., +49-(0)385-520-2710
Christian Güttel, Dr.
- Recruiting
Clinic Trier, Klinikum Mutterhaus der Bromäerinnen
Trier, 54290
Stefan Weis, Dr., +49-(0)651-94782593
Stefan Weis, Dr.
- Recruiting
Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm
Ulm, 89075
Klaus-Michael Debatin, Prof. Dr., +49-(0)731-50057482
Daniel Steinbach, Prof. Dr.
About this study
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
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.
- Keywords
- osteonecrosis, children, pediatric, acute lymphoblastic leukaemia, lymphoblastic lymphoma
- Medical subject headings
- Osteonecrosis, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence of early ON stages
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
Measured: 6 years
Secondary outcomes (1)
ON incidence
Prospective evaluation of incidence of asymptomatic and symptomatic ON in children and adolescents with ALL or LBL
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2016 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu, Heinrich-Heine University, Duesseldorf
- Investigators
- Michaela Kuhlen, Dr. med., Study chair, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619124
- Sponsor's protocol ID
- DKS 2011.11
- Acronym
- OPAL
- Status last verified
- Mar 2014
- First submitted
- 6 Jun 2012
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01619124
- Acronym / sponsor ID
- OPAL / DKS 2011.11
- Keywords
- osteonecrosis, children, pediatric, acute lymphoblastic leukaemia, lymphoblastic lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Klinik für Kinder-Onkologie, -Hämatologie und Klinische ImmuUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma, aged >= 10 and < 18 years
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
ON incidence
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Kuhlen, Dr. med. study chair
Heinrich-Heine University, Duesseldorf
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteonecrosis and Acute Lymphoblastic Leukaemia, run by Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu at 25 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michaela Kuhlen, Dr. med. (+49 211 81 17687, Michaela.Kuhlen@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurence of early ON stages (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.