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

  • STATUS
    Recruiting
  • sponsor
    University of Ulm
Updated on 9 October 2021
Investigator
Hartmut Doehner, MD
Primary Contact
Vivantes Klinikum Spandau (5.9 mi away) Contact
+82 other location
myelodysplastic syndromes
acute leukemia
blast cells

Summary

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

Details
Condition Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), Higher Risk Myelodysplastic Syndromes (MDS With Excess Blasts 2), Higher Risk Myelodysplastic Syndromes (MDS With Excess Blasts 2), Higher Risk Myelodysplastic Syndromes, acute myelogenous leukemia, anll, acute myeloblastic leukemia
Clinical Study IdentifierNCT01252485
SponsorUniversity of Ulm
Last Modified on9 October 2021

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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