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Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler


N/A
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia (AML), Acute Promyelocytic Leukemia (APL), Refractory Anemia With Excess of Blasts (RAEB)

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Trial Information

Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler


Inclusion Criteria:



1. Subjects with a cytopathologically confirmed diagnosis of AML subjects with
refractory anemia with excess of blasts (RAEB) according to the WHO 2008
classification

2. ≥ 18 years

3. Written informed consent

Exclusion Criteria:

1. Subjects without a cytopathologically confirmed diagnosis of AML subjects with
refractory anemia with excess of blasts (RAEB) according to the WHO 2008
classification

2. < 18 years

3. Without written informed consent

Type of Study:

Observational

Study Design:

Observational Model: Case-Only

Outcome Measure:

Acceptance Criteria

Outcome Description:

The acceptance criteria based on lower level of the 95% CI of the positive or negative percent agreement for all markers.

Outcome Time Frame:

Sample taken at initial visit with no follow up (Day 1)

Safety Issue:

No

Principal Investigator

Martin Tallman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

PROT-015

NCT ID:

NCT01463410

Start Date:

October 2011

Completion Date:

March 2013

Related Keywords:

  • Acute Myeloid Leukemia (AML)
  • Acute Promyelocytic Leukemia (APL)
  • Refractory Anemia With Excess of Blasts (RAEB)
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Chromosome Aberrations
  • Chromosome Disorders
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Promyelocytic, Acute

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
James Cancer Hospital Columbus, Ohio  43210