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

Обзор

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)

Первичные конечные точки

• incidence of disease-related genetic markers [Срок оценки: 4 weeks]
• Event-free survival [Срок оценки: 10 years]
• Cumulative incidence of relapse [Срок оценки: 10 years]
• Cumulative incidence of death [Срок оценки: 10 years]
• Overall survival [Срок оценки: 10 years]
• Treatment decision (intensive, non-intensive, investigational) [Срок оценки: 1 year]
• quality of life [Срок оценки: 2 years]
• Geographical representation [Срок оценки: 1 day]
• Response to therapy [Срок оценки: 1 year]
• Relapse-free survival [Срок оценки: 10 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Германия · 86 центров

• Klinikum Aschaffenburg — Aschaffenburg
• Klinikum Augsburg — Augsburg
• Ubbo-Emmius-Klinik Aurich — Aurich
• Helios Klinikum Bad Saarow — Bad Saarow
• Vivantes Klinikum am Urban — Berlin
• Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln — Berlin
• Charité Universitätsmedizin Berlin Campus Virchow Klinikum — Berlin
• Helios Klinikum Emil von Behring — Berlin
• … и ещё 78 центров

Австрия · 8 центров

• Medizinische Universität Graz — Graz
• Medizinische Universität Innsbruck — Innsbruck
• Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. — Linz
• Krankenhaus der Elisabethinen Linz GmbH — Linz
• Kepler Universitätsklinikum GmbH — Linz
• Landeskrankenhaus Feldkirch — Rankweil
• Universitätsklinikum der PMU Landeskrankenhaus Salzburg — Salzburg
• Hanuschkrankenhaus Wien — Vienna

Идентификаторы

NCT: NCT01252485 · AMLSG BiO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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