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. (see Contacts and Locations)
Verified July 2014 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: July 22, 2014
Last verified: July 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 22, 2014
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 August 26, 2014