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Registry Study on Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Acute Leukemias of Ambiguous Lineage - The AMLSG Biology and Outcome (BiO)-Project

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Descriptive Information
Brief Title † Registry Study on Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Acute Leukemias of Ambiguous Lineage - The AMLSG Biology and Outcome (BiO)-Project
Official Title † Registry Study on Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Acute Leukemias of Ambiguous Lineage - The AMLSG Biology and Outcome (BiO)-Project
Brief Summary This is a registry study in adult patients with newly diagnosed AML Investigator's sites: 50-60 sites in Germany and Austria Estimated duration of observation of an individual patient: 10 years maximum Objectives - To register all patients with newly diagnosed AML in all AMLSG participating centers (completeness) - To perform timely analyses of relevant genetic markers (according to WHO 2008 classification) (incidences, treatment decision) - To assess clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS]) - To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers) - To store biosamples from all patients (eg, bone marrow, blood, plasma, buccal swap, sputum, skin biopsy samples) - To assess quality of life
Detailed Description
Study Phase N/A
Study Type † Observational
Study Design † Observational Model: Case-Only, Time Perspective: Prospective
Primary Outcome Measure † Completeness
Secondary Outcome Measure †
Condition † Acute Myeloid Leukemia (AML)
Intervention †
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment †
Start Date † July 2010
Completion Date
Primary Completion Date
Eligibility Criteria † Inclusion Criteria: - Patients with suspected diagnosis of acute myeloid leukemia or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) classification) - Age ≥ 18 years. There is no upper age limit. - No prior chemotherapy* for leukemia except hydroxyurea to control hyperleukocytosis - Signed written informed consent *prior therapy of a preceding myelodysplastic syndrome or myeloproliferative neoplasm is allowed Exclusion Criteria: - Severe neurological or psychiatric disorder interfering with ability to give an informed consent - No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation. - No consent for biobanking of patient's biological specimens and performance of analyses on stored material.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Richard F Schlenk, MD, 49-731-500-45900, richard.schlenk@uniklinik-ulm.de
Location Countries † Germany
Administrative Information
NCT ID † NCT01252485
Organization ID AMLSG BiO
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † University of Ulm
Collaborators ††
Investigators † Study Chair: Richard F Schlenk, MD, University Hospital of Ulm
Information Provided By
Verification Date July 2014
First Received Date † December 2, 2010
Last Updated Date July 22, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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