Clinical trial · Observational
Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 \[OS\]) * To evaluate the impact of measurable residual disease (MRD) by different methods * 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, finger nails, hairs, sputum, or urine)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| MDS/AML | Myelodysplastic Syndrome/Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (11)
- measure
- incidence of disease-related genetic markers
- timeFrame
- 4 weeks
- description
- To perform rapid analyses of disease-related genetic markers (according to International Consensus Classification 2022) (incidences, treatment recommendations)
- measure
- Event-free survival
- timeFrame
- 10 years
- description
- 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 \[OS\])
- measure
- Cumulative incidence of relapse
- timeFrame
- 10 years
- description
- 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 \[OS\])
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available