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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia (AML)

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Completeness

Outcome Description:

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

Safety Issue:

No

Principal Investigator

Richard F Schlenk, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital of Ulm

Authority:

Germany: Registry Study -> no responsible oversight authority

Study ID:

AMLSG BiO

NCT ID:

NCT01252485

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia (AML)
  • AML
  • Registry study
  • Biology and Outcome
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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