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A Pilot Study to Characterize the Genomic and Epigenomic Signature of NPM Positive Vs. NPM Negative NCL


N/A
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

A Pilot Study to Characterize the Genomic and Epigenomic Signature of NPM Positive Vs. NPM Negative NCL


OBJECTIVES:

Primary

- Determine gene expression, genome integrity, cytosine methylation, and chromatin
structure in patients with normal cytogenetics leukemia (NCL) acute myeloid leukemia.

- Determine whether NCL can be deconstructed into specific disease entities by analysis
of the integrated genomic and epigenomic datasets using supervised and unsupervised
methods in these patients.

- Identify the gene pathways that define NCL subtypes and molecular targets for
validation in preclinical and clinical trials for these patients.

- Determine whether integrated analysis provides markers of prognostic and therapeutic
response that accurately predicts clinical outcome and can be used to select patients
for risk-stratified therapeutic trials.

OUTLINE: This is a pilot, multicenter study.

Samples are analyzed to assess array comparative genomic hybridization using polymerase
chain reaction (PCR) and fluorescent in situ hybridization; chromatin immunoprecipitations
(chip) using PCR; Hpa II tiny fragment enrichment by ligation-mediated PCR (HELP) using DNA
methylation analysis; and gene expression profiling.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of acute myeloid leukemia

- Enrolled on clinical trial ECOG-E1900

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Nucleophosmin exon 12 mutation-related normal cytogenetics leukemia (NCL) has a specific genetic and epigenetic profile

Safety Issue:

No

Principal Investigator

Ari M. Melnick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University

Authority:

Unspecified

Study ID:

CDR0000476571

NCT ID:

NCT00897936

Start Date:

Completion Date:

Related Keywords:

  • Leukemia
  • adult acute myeloid leukemia in remission
  • recurrent adult acute myeloid leukemia
  • untreated adult acute myeloid leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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