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 (AMLSG BiO)

This study is currently recruiting participants.
Verified August 2013 by University of Ulm
Sponsor:
Information provided by (Responsible Party):
Dr. Richard Schlenk, University of Ulm
ClinicalTrials.gov Identifier:
NCT01252485
First received: December 2, 2010
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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

Condition
Acute Myeloid Leukemia (AML)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • 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.


Study Start Date: July 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with newly diagnosed AML in all AMLSG participating centers (50-60 centers in Germany and Austria)

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252485

Contacts
Contact: Richard F Schlenk, MD 49-731-500-45900 richard.schlenk@uniklinik-ulm.de

Locations
Germany
University Hospital of Ulm Recruiting
Ulm, Germany, 89081
Contact: Richard F Schlenk, MD    49-731-500-45900    richard.schlenk@uniklinik-ulm.de   
Sponsors and Collaborators
University of Ulm
Investigators
Study Chair: Richard F Schlenk, MD University Hospital of Ulm
  More Information

No publications provided

Responsible Party: Dr. Richard Schlenk, PD Dr., University of Ulm
ClinicalTrials.gov Identifier: NCT01252485     History of Changes
Other Study ID Numbers: AMLSG BiO
Study First Received: December 2, 2010
Last Updated: August 30, 2013
Health Authority: Germany: Registry Study -> no responsible oversight authority

Keywords provided by University of Ulm:
AML
Registry study
Biology and Outcome

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 20, 2014