Registry Study on Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Acute Leukemias of Ambiguous Lineage - The AMLSG Biology and Outcome (BiO)-Project
Conditions
Acute Myeloid Leukemia (AML)
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
AML, Registry study, Biology and Outcome
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Overall Status
Recruiting
Summary
This is a registry study in adult patients with newly diagnosed AML

Investigator's sites: 50-60 sites in Germany and Austria

Estimated duration of observation of an individual patient:

10 years maximum

Objectives

- To register all patients with newly diagnosed AML in all AMLSG participating centers (completeness)

- To perform timely analyses of relevant genetic markers (according to WHO 2008 classification) (incidences, treatment decision)

- To assess clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])

- To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)

- To store biosamples from all patients (eg, bone marrow, blood, plasma, buccal swap, sputum, skin biopsy samples)

- To assess quality of life
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with suspected diagnosis of acute myeloid leukemia or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) classification)

- Age ≥ 18 years. There is no upper age limit.

- No prior chemotherapy* for leukemia except hydroxyurea to control hyperleukocytosis

- Signed written informed consent *prior therapy of a preceding myelodysplastic syndrome or myeloproliferative neoplasm is allowed

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 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.
Location
University Hospital of Ulm
Ulm, Germany
Status: Recruiting
Contact: Richard F Schlenk, MD - 49-731-500-45900 - richard.schlenk@uniklinik-ulm.de
Start Date
July 2010
Sponsors
University of Ulm
Source
University of Ulm
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page