Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome
This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms Investigator's sites: 80-90 sites in Germany and Austria Estimated duration of observation of an individual patient: 10 years maximum Objectives * To register all patients with AML and related neoplasms, newly diagn
| Condition(s) | Acute Myeloid Leukemia (AML), MDS/AML |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms Investigator's sites: 80-90 sites in Germany and Austria Estimated duration of observation of an individual patient: 10 years maximum Objectives * To register all patients with AML and related neoplasms, newly diagnosed or relapsed/refractory in all AMLSG participating centers (completeness) * To perform rapid analyses of disease-related genetic markers (incidences, treatment recommendations) * To assess patient and family history, as well as patient characteristics * To evaluate treatment response (CR, CRh, CRi) and outcome data (event-free survival \[EFS\], relapse-free survival \[RFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \ |
| Who can participate | Inclusion Criteria: * Patients with suspected diagnosis of acute myeloid leukemia and related neoplasms, newly diagnosed or relapsed/refractory, classified according to the International Consensus 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 | 18 Years |
| Sex | All |
| Lead sponsor | University of Ulm |
| Locations | Graz, Austria; Innsbruck, Austria; Linz, Austria; Linz, Austria; Linz, Austria; Rankweil, Austria (+88 more sites) |
| Start date | 2010-07-06 |
| NCT ID | NCT01252485 |
| Official listing | https://clinicaltrials.gov/study/NCT01252485 |