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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Acute Myeloid Leukemia (AML), Higher Risk Myelodysplastic Syndromes (MDS With Excess Blasts 2)

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of disease-related genetic markers | To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations) | 4 weeks | 
| Event-free survival | 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]) | 10 years | 
| Cumulative incidence of relapse | 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]) | 10 years | 
| Cumulative incidence of death | 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]) | 10 years | 
| Overall survival | 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]) | 10 years | 
| Treatment decision (intensive, non-intensive, investigational) | To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations) | 1 year | 
| quality of life | 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. | 5 years | 
| Geographical representation | Geographical representation of patients through collection of patients zip codes | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, Registry study, Biology and Outcome, Higher Risk MDS