Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project (AMLSG BiO)

University of Ulm

Status: Enrolling

Conditions: Acute Myeloid Leukemia (AML); MDS/AML

Study type: Observational

Funder types: Other

Identifiers

NCT01252485

AMLSG BiO

Details and patient eligibility

About

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)

Enrollment: 50,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.