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Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Higher Risk Myelodysplastic Syndrome - The Biology and Outcome (BiO)-Project (AMLSG BiO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by University of Ulm
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Hartmut Doehner, University of Ulm
ClinicalTrials.gov Identifier:
NCT01252485
First received: December 2, 2010
Last updated: September 9, 2016
Last verified: September 2016

December 2, 2010
September 9, 2016
July 2010
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  • incidence of disease-related genetic markers [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)
  • Event-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • Cumulative incidence of relapse [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • Cumulative incidence of death [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • Treatment decision (intensive, non-intensive, investigational) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)
  • quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, socioeconomics, and demographics according to Messerer D et al (2008) initially, in first CR, one year, 3 and 5 years after initial diagnosis.
  • Geographical representation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Geographical representation of patients through collection of patients zip codes
  • Completeness [ Designated as safety issue: No ]
    To register all patients with newly diagnosed AML in all AMLSG participating centers (completeness)
  • incidence of relevant genetic markers [ Designated as safety issue: No ]
    To perform timely analyses of relevant genetic markers (according to WHO 2008 classification) (incidences, treatment decision)
  • Event-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To assess clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • Cumulative incidence of relapse [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To assess clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • Cumulative incidence of death [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To assess clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    To assess clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • Treatment decision (intensive, non-intensive, investigational) [ Designated as safety issue: No ]
    To perform timely analyses of relevant genetic markers (according to WHO 2008 classification) (incidences, treatment decision)
  • quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics according to Messerer et al [40] initially, in first CR, one year, 3 and 5 years after initial diagnosis.
Complete list of historical versions of study NCT01252485 on ClinicalTrials.gov Archive Site
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Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Higher Risk Myelodysplastic Syndrome - The Biology and Outcome (BiO)-Project
Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Higher Risk Myelodysplastic Syndrome - The Biology and Outcome (BiO)-Project

This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms

Investigator's sites: 60-70 sites in Germany and Austria

Estimated duration of observation of an individual patient:

10 years maximum

Objectives

  • To register all patients with acute myeloid leukemia and related precursor neoplasms, acute leukemia of unambiguous lineage, with higher risk myelodysplastic syndromes (MDS with excess blasts 2), and with myeloid neoplasms with germline predisposition, newly diagnosed or relapsed/refractory in all participating centers (completeness)
  • To perform timely analyses of disease-related genetic markers (incidences, treatment recommendations)
  • To assess patient and family history, 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 (e.g., bone marrow, blood, plasma, normal tissue, e.g., skin biopsy, buccal swap, finger nails, hairs, or sputum)
  • To assess quality of life
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
patients with newly diagnosed or relapsed/refractory AML in all AMLSG participating centers (60-70 centers in Germany and Austria)
  • Acute Myeloid Leukemia (AML)
  • Higher Risk Myelodysplastic Syndromes (MDS With Excess Blasts 2)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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Inclusion Criteria:

  • Patients with suspected diagnosis of AML and related precursor neoplasms, acute leukemias of ambiguous lineages, higher risk MDS (MDS with excess blasts 2 [MDS-EB2]), and myeloid neoplasm with germline predisposition, newly diagnosed or relapsed/refractory, classified according to the World Health Organization (WHO) classification
  • Age ≥ 18 years. There is no upper age limit.
  • Signed written informed consent

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 patient and 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.
Both
18 Years and older   (Adult, Senior)
No
Contact: Hartmut Döhner, Prof. Dr. 49-731-500-45501 hartmut.doehner@uniklinik-ulm.de
Austria,   Germany
 
NCT01252485
AMLSG BiO
No
Not Provided
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Prof. Dr. Hartmut Doehner, University of Ulm
University of Ulm
Not Provided
Study Chair: Hartmut Döhner, Prof. Dr. University Hospital of Ulm
University of Ulm
September 2016

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