Brief 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
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.
Primary outcome:
1. incidence of disease-related genetic markers (Time Frame - 4 weeks):
To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)
2. Event-free survival (Time Frame - 10 years):
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])
3. Cumulative incidence of relapse (Time Frame - 10 years):
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])
4. Cumulative incidence of death (Time Frame - 10 years):
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])
5. Overall survival (Time Frame - 10 years):
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])
6. Treatment decision (intensive, non-intensive, investigational) (Time Frame - 1 year):
To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)
7. 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, socioeconomics, and demographics according to Messerer D et al (2008) initially, in first CR, one year, 3 and 5 years after initial diagnosis.
8. Geographical representation (Time Frame - 1 day):
Geographical representation of patients through collection of patients zip codes
Quelle: ClinicalTrials.gov
