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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00013030 |
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Date of registration:
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26/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Register AML-BFM 2017 for the registration of acute myelogenous leukemia in children and adolescents
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Scientific title:
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Register AML-BFM 2017 for the registration of acute myelogenous leukemia in children and adolescents - Register AML-BFM 2017 |
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Date of first enrolment:
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13/12/2017 |
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Target sample size:
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1000 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00013030 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
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Phase:
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Countries of recruitment
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Austria
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Czechia
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Germany
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Slovakia
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Switzerland
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Contacts
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Name:
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Reinhardt
Dirk |
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Address:
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Hufelandstr. 55
47122
Essen
Germany |
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Telephone:
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+49(0)201 723 3755 |
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Email:
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dirk.reinhardt@uk-essen.de |
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Affiliation:
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AML-BFM studiengruppe, Universitätskinderklinik III |
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Name:
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Reinhardt
Dirk |
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Address:
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Hufelandstr. 55
47122
Essen
Germany |
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Telephone:
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+49(0)201 723 3755 |
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Email:
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dirk.reinhardt@uk-essen.de |
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Affiliation:
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AML-BFM studiengruppe, Universitätskinderklinik III |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Age 0 - <18 years
• de novo AML, Myeloid sarcoma, Acute Mixed Lineage Leukemia/ bi-phenotypic Leukemia (dominant myeloid acc. to WHO 2008) or
• AML as secondary malignant tumor or
• Transient Leukemias and Myeloid Leukemia in Trisomy 21 or
• Relapsed/refractory AML in children and adolescents or
• “Special" cases of AML-associated diseases after consultation with and approval by the Register chair
• Admission to an accredited pediatric oncology center acc. to GBA resolution “Pediatric Oncology”
• Existence of all necessary Informed Consent Forms
Exclusion criteria: • Missing Informed Consent Forms oft he patient and/or his/her legal representative
Age minimum:
0 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute myeloblastic leukaemia [AML]
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Acute myelogenous leukemia
C92.0
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C92.0
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Intervention(s)
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Group 1: Data Registration of all childhood AML-cases
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Primary Outcome(s)
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1.Registration of all AML diseases and their treatment in children and adolescents in the participating centers of all participating countries
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Secondary Outcome(s)
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2. Registration of genetic, molecular genetic and epigenetic characteristics of AML in children and adolescents
3. Determination of minimal residual disease (MRD) via morphology, immunophenotyping and molecular genetic
4. Registration of the frequency and kinetic of a molecular relapse
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Source(s) of Monetary Support
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GPOH gemeinnützige GmbH, AML-BFM Studienzentrale
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Ethics review
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Status: Approved
Approval date: 22/05/2017
Contact:
ethikkommission@uk-essen.de
Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
+49-201-7233637
ethikkommission@uk-essen.de
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