Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003803

Trial Description

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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

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Trial Acronym

AMLSG BiO

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003803
  •   2012/04/24
  •   2010/12/02
  •   yes
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Secondary IDs

  •   NCT01252485  (ClinicalTrials.gov)
  •   AMLSG BiO  (University of Ulm)
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Health Condition or Problem studied

  •   Acute Myeloid Leukemia (AML)
  •   C92.0 -  Acute myeloid leukaemia
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Completeness; To register all patients with newly diagnosed AML in all AMLSG participating centers (completeness)
- incidence of relevant genetic markers; To perform timely analyses of relevant genetic markers (according to WHO 2008 classification) (incidences, treatment decision)
- Event-free survival; time frame: 10 years; 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; 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; 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; 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); To perform timely analyses of relevant genetic markers (according to WHO 2008 classification) (incidences, treatment decision)
- quality of life; time frame: 5 years; 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.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2010/07/31
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  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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.

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Addresses

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    • University of Ulm
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    • University Hospital of Ulm
    • Richard F Schlenk, MD 
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  • start of 1:1-Block address public-contact
    • Richard F Schlenk, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   47
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.