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

Recruiting

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

• Registration Number: NCT01252485
• Lead Sponsor: University of Ulm

Brief 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 \[OS\])

* 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-06
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Status Verified: 2024-11
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-08
• Primary Completion: 2044-12-31
• Study Completion: 2044-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of disease-related genetic markers	4 weeks	To perform rapid analyses of disease-related genetic markers (according to International Consensus Classification 2022) (incidences, treatment recommendations)
Event-free survival	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 \[OS\])
Cumulative incidence of relapse	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 \[OS\])
Cumulative incidence of death	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 \[OS\])
Overall survival	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 \[OS\])
Treatment decision (intensive, non-intensive, investigational)	1 year	To perform rapid analyses of disease-related genetic markers (according to ICC 2022) (incidences, treatment recommendations)
quality of life	2 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), 6, 12 and 24 months after registration.
Response to therapy	1 year	Rate of response: complete remission (CR), CR with partial hematologic recovery (CRh); CR with incomplete hematologic recovery (CRi)
Relapse-free survival	10 years
Measurable residual disease (MRD)	10 years
Geographical representation	1 day	Geographical representation of patients through collection of patients zip codes

Trial Locations

Locations (90)

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria

Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.; 🇦🇹 Linz, Austria

Krankenhaus der Elisabethinen Linz GmbH; 🇦🇹 Linz, Austria

Kepler Universitätsklinikum GmbH; 🇦🇹 Linz, Austria

Landeskrankenhaus Feldkirch; 🇦🇹 Rankweil, Austria

Universitätsklinikum der PMU Landeskrankenhaus Salzburg; 🇦🇹 Salzburg, Austria

Hanuschkrankenhaus Wien; 🇦🇹 Wien, Austria

Klinikum Aschaffenburg; 🇩🇪 Aschaffenburg, Germany

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

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